AccessGUDID - DEVICE: Therastep Gel Bunion Cushion Fr/Eng, 1/blister (00614464070549)

GUDID

Device Identifier (DI) Information

Brand Name: Therastep Gel Bunion Cushion Fr/Eng, 1/blister
Version or Model: 7054
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Silipos Holding LLC

Primary DI Number: 00614464070549
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 056112948 *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?
13565	Bunion shield	A pad used to protect a bunion that has formed on the base of the big toe. It is typically ring-shaped, made of a thick material and worn over the bunion. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, Skin Pressure

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: a72eb862-7d23-4091-bb5d-4eeca24d7c58
Public Version Date: September 01, 2022
Public Version Number: 1
DI Record Publish Date: August 24, 2022