CollaSorb 1g Powder 906003

GUDID 00612553000019

CollaSorb Powder Collagen Wound Filler

HARTMANN USA, INC.

Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing Collagen wound matrix dressing

• Primary Device ID: 00612553000019
• NIH Device Record Key: 799e0b96-e268-49d4-8bdb-39f553c363a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CollaSorb 1g Powder
• Version Model Number: 906003
• Catalog Number: 906003
• Company DUNS: 010137511
• Company Name: HARTMANN USA, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 64 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612553000002 [Primary]
GS1	00612553000019 [Package]; Contains: 00612553000002; Package: FBX [10 Units]; In Commercial Distribution
GS1	00612553000026 [Package]; Package: CS [10 Units]; In Commercial Distribution

FDA Product Code

• KGN: Wound Dressing With Animal-Derived Material(S)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-28
• Device Publish Date: 2024-03-20

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