ColActive Plus 2x2

GUDID 30612553024276

ColActive Plus 2x2

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

• Primary Device ID: 30612553024276
• NIH Device Record Key: b1187956-9f0c-4046-8f03-12554308aac0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ColActive Plus 2x2
• Version Model Number: 10160000
• 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	10612553024272 [Package]; Contains: 20612553024279; Package: CS [10 Units]; In Commercial Distribution
GS1	20612553024279 [Package]; Package: FBX [10 Units]; In Commercial Distribution
GS1	30612553024276 [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: 2024-05-14ColActive Plus 2x2
• 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: 2024-05-14 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