AccessGUDID - DEVICE: GelShot (00853904006377)

GUDID

Device Identifier (DI) Information

Brand Name: GelShot
Version or Model: GSA5RM1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: COMPASS HEALTH BRANDS CORP.

Primary DI Number: 00853904006377
Issuing Agency: GS1
Commercial Distribution End Date: September 26, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 827221698 *Terms of Use

Device Description: GelShot-/Adaptor-Richmar 5 cm

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:	Yes
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?
62411	Ultrasound coupling pad holder	A non-sterile device intended to hold an ultrasound coupling pad (not included) over the distal end of a noninvasive therapeutic ultrasound system applicator during treatment. It is typically a small attachment with a window designed to support the coupling pad in place while not obstructing transmission of ultrasound. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUI	Media,Coupling,Ultrasound

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 3ace1796-0dfb-4262-8dc9-bc46dde98df0
Public Version Date: September 13, 2023
Public Version Number: 5
DI Record Publish Date: September 01, 2016