ColActive® Transfer 4x4
GUDID 00825439013489
Wound contact layer
Covalon Technologies Ltd
Collagen wound matrix dressing| Primary Device ID | 00825439013489 |
| NIH Device Record Key | b25073a5-caea-4b3e-9e89-96691bd0ebed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ColActive® Transfer 4x4 |
| Version Model Number | 5550441 |
| Company DUNS | 206936101 |
| Company Name | Covalon Technologies Ltd |
| 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 Dimensions
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
| Length | 4 Inch |
| Width | 4 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00825439013472 [Primary] |
| GS1 | 00825439013489 [Package] Contains: 00825439013472 Package: Carton [10 Units] In Commercial Distribution |
| GS1 | 10825439013493 [Package] Package: Shipper [10 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K123756
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 | 2022-12-13 |
| Device Publish Date | 2022-12-05 |
Devices Manufactured by Covalon Technologies Ltd
| 00825439017487 - CovaClear™ IV Cover 4x4 | 2024-09-09 Clear Silicone Adhesive Securement Dressing |
| 00825439017500 - CovaClear™ IV Cover 6x7 | 2024-09-09 Clear Silicone Adhesive Securement Dressing |
| 00825439017524 - CovaClear™ IV Cover 10x12 | 2024-09-09 Clear Silicone Adhesive Securement Dressing |
| 00825439017548 - CovaClear™ IV 10x12 | 2024-09-09 Clear Silicone Adhesive Securement Dressing |
| 00825439011393 - CovaWound™ Silicone 10x10 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border |
| 00825439011416 - CovaWound™ Silicone 12.5x12.5 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border |
| 00825439011430 - CovaWound™ Silicone 15x15 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border |
| 00825439011454 - CovaWound™ Silicone 15x20 | 2024-04-16 Self-Adherent Soft Silicone Foam Dressing with Border |
Trademark Results [ColActive]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COLACTIVE 77160880 3689817 Live/Registered |
Covalon Technologies Ltd. 2007-04-19 |
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