AccessGUDID - DEVICE: ALLEVYN LIFE M 12.9X12.9 CTN10 (05000223478018)

GUDID

Device Identifier (DI) Information

Brand Name: ALLEVYN LIFE M 12.9X12.9 CTN10
Version or Model: 66801068
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66801068, 66021068
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 05000223478018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: Soft Silicone Hydrocellular Foam Dressing with Lock Away 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":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
44970	Exudate-absorbent dressing, non-gel, non-antimicrobial	A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAD	Dressing, Wound, Occlusive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: c7cdff66-cbf8-4c35-9acf-9616c21f0e24
Public Version Date: September 07, 2023
Public Version Number: 5
DI Record Publish Date: May 15, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
05000223478025	10	05000223478018	In Commercial Distribution	carton 66801068
05000223478032	5	05000223478025	In Commercial Distribution	case 66801068
05000223490218	10	05000223478025	In Commercial Distribution	carton 66021068
05000223490225	5	05000223490218	In Commercial Distribution	case 66021068