AccessGUDID - DEVICE: SiliGentle Non-Adhesive Silicone Foam Dressing (00616784305714)

GUDID

Device Identifier (DI) Information

Brand Name: SiliGentle Non-Adhesive Silicone Foam Dressing
Version or Model: 3057
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Dynarex Corporation

Primary DI Number: 00616784305714
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008124539 *Terms of Use

Device Description: SiliGentle Non-Adhesive Silicone Foam Dressing, 6"x6", Non-Bordered

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":	Yes
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?
60470	Pressure-management bandage, silicone	A non-sterile piece of silicone material intended to be worn over pressure-point areas of the body to help prevent the development of, and/or treat, pressure and friction sores in patients with restricted mobility. It is available in various shapes (e.g.,, concave shapes for the heel or elbow, pads for the sacrum, and sheets or strips for other areas of the body) and sizes, and may be used in a healthcare facility or in the home. This is a single-patient, reusable device.	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: 16028d70-4923-42cc-a349-5f9be0cc5b26
Public Version Date: October 09, 2024
Public Version Number: 2
DI Record Publish Date: June 21, 2021