AccessGUDID - DEVICE: Suprasorb H (08800048000107)

GUDID

Device Identifier (DI) Information

Brand Name: Suprasorb H
Version or Model: HD14EN26
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 108867
Company Name: T&L Co.,Ltd.

Primary DI Number: 08800048000107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694747496 *Terms of Use

Device Description: Suprasorb® H Hydrocolloid Dressing has a two layer construction composed of an absorbent hydrocolloid matrix laminated to a breathable polyurethane flm backing. Hydrocolloid matrix rapidly absorbs exudate to form a cohesive gel. In addition to excellent absorbency, the breathable polyurethane flm backing provides a consistently high rate of moisture vapor transmission. Together, these features ensure an optimal moist wound environment, minimize the chance for damage to healthy peri-wound skin and provide wear time for up to seven days.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
43186	Exudate-absorbent dressing, hydrophilic-gel, non-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; it does not contain an antimicrobial agent. The device 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. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, 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: dca6a59a-f58b-4662-a7dc-7c949807ca0e
Public Version Date: July 22, 2021
Public Version Number: 2
DI Record Publish Date: February 10, 2021