AccessGUDID - DEVICE: ColActive® Transfer 4x4 (00825439013472)

GUDID

Device Identifier (DI) Information

Brand Name: ColActive® Transfer 4x4
Version or Model: 5550441
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Covalon Technologies Ltd

Primary DI Number: 00825439013472
Issuing Agency: GS1
Commercial Distribution End Date: November 02, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 206936101 *Terms of Use

Device Description: Wound contact layer

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45023	Collagen wound matrix dressing	A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGN	Wound Dressing With Animal-Derived Material(S)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123756	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 4 Inch
Width: 4 Inch

Device Record Status

Public Device Record Key: b25073a5-caea-4b3e-9e89-96691bd0ebed
Public Version Date: November 03, 2023
Public Version Number: 2
DI Record Publish Date: December 05, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00825439013489	10	00825439013472	2023-11-02	Not in Commercial Distribution	Carton
10825439013493	10	00825439013489	2023-11-02	Not in Commercial Distribution	Shipper