AccessGUDID - DEVICE: Skinergy Plus (05055348232786)

GUDID

Device Identifier (DI) Information

Brand Name: Skinergy Plus
Version or Model: Closed Toe TrueFinish™ Skinergy Plus 22/23 Left Large Colour E12
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TNS22LL/E12
Company Name: HUGH STEEPER LIMITED

Primary DI Number: 05055348232786
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 210280350 *Terms of Use

Device Description: No description.

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:	No
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?
64736	External limb prosthesis finishing component, non-customized	A prefabricated cosmetic component of an external upper or lower limb prosthesis designed to provide an aesthetic outer shape and surface to the prosthesis via one of various forms (e.g., foot shell, filler, skin, stocking, glove, limb cover) ready to be assembled, fitted, and adjusted to the patient. It may be made of various materials (e.g., foam, thermoplast, wood, silicone, fibreglass, resin, carbon fibre), and may additionally be designed to protect the prosthesis from external agents (e.g., debris, water splashes, impact forces).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPM	Cover, Limb

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: No
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: 40c92a01-7773-4904-966c-76e959ab6a16
Public Version Date: July 26, 2023
Public Version Number: 1
DI Record Publish Date: July 18, 2023