AccessGUDID - DEVICE: ALLEVYN Gentle Border Sacrum (05000223476120)

GUDID

Device Identifier (DI) Information

Brand Name: ALLEVYN Gentle Border Sacrum
Version or Model: 66020413
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66020413, 66800898
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 05000223476120
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: ALLEVYN Gentle Border Sacrum Silicone gel adhesive hydrocellular sacrum dressing

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: f40493bb-ec3b-4278-80d4-d8fa67c3a34e
Public Version Date: September 07, 2023
Public Version Number: 6
DI Record Publish Date: July 04, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
05000223483081	10	05000223476120	In Commercial Distribution	Carton
05000223476137	10	05000223476120	In Commercial Distribution	carton 66800898
05000223476144	6	05000223476137	In Commercial Distribution	case 66800898
05000223483098	6	05000223483081	In Commercial Distribution	case 66020413