AccessGUDID - DEVICE: AQUACEL AG EXTRA (00768455127405)

GUDID

Device Identifier (DI) Information

Brand Name: AQUACEL AG EXTRA
Version or Model: 420676
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 420676
Company Name: CONVATEC, PURCHASING DEPARTMENT

Primary DI Number: 00768455127405
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 809784593 *Terms of Use

Device Description: AQUACEL AG EXTRA 10X10CM(1X10PK)STER NAI

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":	No
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?
47474	Exudate-absorbent dressing, hydrophilic-gel, antimicrobial	A wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment while reducing microbial colonization within the dressing. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121275	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 10 Centimeter
Length: 10 Centimeter

Device Record Status

Public Device Record Key: 862a03f0-67d2-4084-a3f9-146e7ae38020
Public Version Date: May 23, 2022
Public Version Number: 6
DI Record Publish Date: August 22, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00768455127412	10	00768455127405	2022-05-20	Not in Commercial Distribution	Carton
10768455127419	20	00768455127412	2022-05-20	Not in Commercial Distribution	Carton