AccessGUDID - DEVICE: Wound Compresses 100mm x 100mm (04007418920735)

GUDID

Device Identifier (DI) Information

Brand Name: Wound Compresses 100mm x 100mm
Version or Model: 92073
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hans Hepp GmbH & Co. KG

Primary DI Number: 04007418920735
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315896217 *Terms of Use

Device Description: A sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. This is a single-use device.

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):	Yes
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?
34084	Wound compression dressing	A sterile covering designed to exert pressure on a wounded area to prevent the collection of fluids in the underlying tissues; most commonly used after skin grafting and in the treatment of burns. 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: 85972973-6812-4b07-9dce-567e4342d4e3
Public Version Date: August 02, 2023
Public Version Number: 1
DI Record Publish Date: July 25, 2023