AccessGUDID - DEVICE: CONFORMANT 2 WND VL 15CM x 1.8M CS 20 (00040565119380)

GUDID

Device Identifier (DI) Information

Brand Name: CONFORMANT 2 WND VL 15CM x 1.8M CS 20
Version or Model: 5955602
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5955602
Company Name: SMITH & NEPHEW MEDICAL LIMITED

Primary DI Number: 00040565119380
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 216344051 *Terms of Use

Device Description: Polyethylene 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":	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?
46735	Fluid-permeable film dressing	A sterile, transparent covering that is permeable to fluids intended to be applied to wounded or diseased tissue to provide protection (e.g., from dirt, microbes) and/or promote healing. It is a thin, clear, hydrophilic membrane made of synthetic polymer (e.g., polyurethane based) without an adhesive. It is applied directly to tissue to protect and/or help heal (e.g., as a synthetic skin) burns, skin-graft donor sites, ulcers, laser resurfacing sites, or other partial-thickness wounds. Its permeability allows the passage of wound exudates without removal; the device may be perforated (e.g., meshed) for increased permeability for highly-exudative wounds. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAC	Dressing, Wound, Hydrophilic

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: d0d597c5-36cc-42c6-b212-d7c913ad0051
Public Version Date: September 07, 2023
Public Version Number: 3
DI Record Publish Date: July 16, 2020