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EXPANDING DRESSING FOR NOSE AND EARS MATERIAL SAFETY DATA SHEET Product name : Expanding dressing for Nose and Ears with X-ray detectable stringRef: 00650 - 00654 Product and Company Identification Product name: Expanding Dressing for Nose & Ears With X-Ray Detectable StringIntended Use: Non-absorbable Sponge for Internal/External Use Supplier: Manufacturer: Pollak (International) Ltd Tel: 972 3 9022885 Fax: 972 3 9024531 Composition/Information on Ingredients: Compressed cellulose as in E.P, U.S.P, B.P, Martindale Pharmacopoeia and the Pharmaceutical Codex 11th Edition. X-Ray thread is used for more than 40 years in various medical procedures, and conforms to BPC 1973. Hazards Identification: Emergency Overview: No Hazards to Incidental or Prolonged Exposures Signs and Symptoms of Overexposure Eyes: Prolonged exposure or repeated exposures not
likely to cause eye irritation. Oral and nasal toxicity is unlikely as the ingredients are in the various Pharmacopoeias with no remark about toxicity. Inhalation: At room temperatures, exposures to vapors are unlikely. Effects of Chronic Exposure: ND Medical Conditions Aggravated: ND First Aid Measures Eyes: No adverse effects anticipated by this route of exposure Skin: No adverse effects anticipated by this route of exposure Ingestion: Monitor individual in normal manner for the
ingestion of any non-toxic material. Fire Fighting Measures Flash point and Method: ND Hazardous combustion Products: None Fire and Exposure Hazards: Hazardous Polymerization will occur Special Firefighting Instruction: None. Accidental Release Measures: Material is sponge solid no spillage measures are required Handling and Storage Refer to specification product labeling for storage conditions. KEEP DRY, Avoid high humidity. Exposure Control/Personal Protection No hazards exist requiring exposure control or protection Physical and Chemical Properties Physical state: Porous sponge: Compressed cellulose. Appearance: Natural color; yellowish. Odor: None Solubility in water: Negligible conforms to Pharmacopoeia requirements. Absorbency: 735% of its own weight. Melting Point: 70o C pH: 7± 0.2 Stability and Reactivity Hazardous Polymerization will not occur Compatibility with other material has not been established, but can be smeared with antibiotic ointment before insertion. Toxicological Information: Materials have been tested for citotoxicity according to USP XXIII and ISO 10993; Allergic sensitivity according to ASTM F 720-81 and ISO 10993-10; results were O.K. Material is known for proven biocompatibility. Product is supplied sterile, in a double peel apart sachet (Level I). 100 packs in a carton wrapped in poly protection against humidity. Ecological Information: NE Disposal Considerations: Dispose or incinerate in accordance with all applicable regulations for disposed medical products. Transportation Information: No specific requirements to be met; not regulated as a hazardous material. Regulatory Information: NE. Other Information: Legends: NA= not applicable NE = Not Established ND = Not Determined Approved by: POLLAK (INTERNATIONAL) LTD – Quality Assurance Approval Date November 7th, 2004 : Note: The information on this MSDS represents our current data and best opinion as to the proper use in handling of this product under the normal conditions of its use. Any use of this product which is not in conformance with the data sheet or product labeling, or which involves the product in combination with any other material or processes or interactions is the responsibility of the user.
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