CollaSorb 1g Powder 906003

GUDID 00612553000019

CollaSorb Powder Collagen Wound Filler

HARTMANN USA, INC.

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

Devices Manufactured by HARTMANN USA, INC.

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• 30612553024283 - ColActive Plus 4x4: 2024-05-14 ColActive Plus 4x4
• 20612553024293 - COLACTIVE PLUS 7x7 10/BX: 2024-05-14 COLACTIVE PLUS 7x7 10/BX
• 30612553024306 - ColActive Plus AG 2x2 600/cs: 2024-05-14 ColActive Plus AG 2x2 600/cs
• 30612553024313 - ColActive Plus AG 4x4 300/cs: 2024-05-14 ColActive Plus AG 4x4 300/cs
• 30612553024320 - COLACTIVE PLUS AG 7x7 10/BX: 2024-05-14 COLACTIVE PLUS AG 7x7 10/BX
• 00612553000019 - CollaSorb 1g Powder: 2024-03-28CollaSorb Powder Collagen Wound Filler
• 00612553000019 - CollaSorb 1g Powder: 2024-03-28 CollaSorb Powder Collagen Wound Filler
• 10612553024395 - AC-TAPE PLUS: 2024-01-24 AC-TAPE PLUS 3X5 48/CS