AccessGUDID - DEVICE: Adam's Skin (08057971593927)

GUDID

Device Identifier (DI) Information

Brand Name: Adam's Skin
Version or Model: AS02-RS1-N2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIONIT LABS SRL

Primary DI Number: 08057971593927
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 439080477 *Terms of Use

Device Description: Adam's Skin - Glove for Adam's Hand (spare part) - Basic Glove - Color: N2 - Side: Right - Size: Small

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):	Yes
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?
41497	Myoelectric hand prosthesis	A powered 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 replace the appearance and some of the function of the hand. The device features an integral or proximally mounted motor (e.g., electric, hydraulic) which actuates hand/finger movements (e.g., gripping, pinching, pointing). The control of movement is achieved through amplified muscle action potentials from voluntary contracting muscle in the residual limb/trunk, transmitted via surface electrodes in the device that make contact with the skin, which turn on the motor to provide a function.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQZ	Hand, External Limb Component, Powered

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
Handling Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 352a8565-2420-453b-919d-b8c599855398
Public Version Date: May 22, 2025
Public Version Number: 2
DI Record Publish Date: April 03, 2025