COLACTIVE PLUS 7x7 10/BX

GUDID 20612553024293

COLACTIVE PLUS 7x7 10/BX

HARTMANN USA, INC.

Collagen wound matrix dressing

• Primary Device ID: 20612553024293
• NIH Device Record Key: a52c01a6-cb32-4769-9518-f6cea3edbbc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COLACTIVE PLUS 7x7 10/BX
• Version Model Number: 10350000
• Company DUNS: 010137511
• Company Name: HARTMANN USA, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10612553024296 [Package]; Package: CS [10 Units]; In Commercial Distribution
GS1	20612553024293 [Package]; Contains: 30612553024290; Package: FBX [10 Units]; In Commercial Distribution
GS1	30612553024290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060804

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-05-14
• Device Publish Date: 2020-09-01

Devices Manufactured by HARTMANN USA, INC.

• 30612553024276 - ColActive Plus 2x2: 2024-05-14 ColActive Plus 2x2
• 30612553024283 - ColActive Plus 4x4: 2024-05-14 ColActive Plus 4x4
• 20612553024293 - COLACTIVE PLUS 7x7 10/BX: 2024-05-14COLACTIVE PLUS 7x7 10/BX
• 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: 2024-03-28 CollaSorb Powder Collagen Wound Filler
• 10612553024395 - AC-TAPE PLUS: 2024-01-24 AC-TAPE PLUS 3X5 48/CS