AccessGUDID - DEVICE: COSMETIC HAND (05055348256850)

GUDID

Device Identifier (DI) Information

Brand Name: COSMETIC HAND
Version or Model: Infants Foam Filled PVC Glove Infants Right 7 E14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AH45/26/E14
Company Name: HUGH STEEPER LIMITED

Primary DI Number: 05055348256850
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?
41078	Passive hand prosthesis	An artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to move only as a result of the direct application of external forces.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRA	Hand, External Limb Component, Mechanical

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: 264a23e1-6656-4903-8f5a-1a0f91141bad
Public Version Date: July 10, 2023
Public Version Number: 1
DI Record Publish Date: June 30, 2023