AccessGUDID - DEVICE: PUTTY LIGHT BLUE X-SOFT 4OZ 0.2 LBS PER 4 OZ CONTAINER (00733657206524)

GUDID

Device Identifier (DI) Information

Brand Name: PUTTY LIGHT BLUE X-SOFT 4OZ 0.2 LBS PER 4 OZ CONTAINER
Version or Model: 5632
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2970003549
Company Name: ALIMED, INC.

Primary DI Number: 00733657206524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056007248 *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":	Yes
For Single-Use:	No
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?
34200	Finger/hand exerciser	A non-powered device intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity, density, magnetism, or other means. It is available in a variety of forms including handgrips (some types with individual buttons to work each finger independently), elastic balls and webs, putty, and hand-held devices with elastic bands. The device may also help improve finger/hand flexibility and coordination, and help improve wrist and forearm strength.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ION	EXERCISER, NON-MEASURING

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: d4fa603e-0fe4-4a5a-b477-ed75a6716571
Public Version Date: February 19, 2024
Public Version Number: 2
DI Record Publish Date: December 01, 2022