AccessGUDID - DEVICE: RACEGEL (03760140703359)

GUDID

Device Identifier (DI) Information

Brand Name: RACEGEL
Version or Model: 01C0500
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 01C0500
Company Name: SEPTODONT SAS SPECIALITES SEPTODONT

Primary DI Number: 03760140703359
Issuing Agency: GS1
Commercial Distribution End Date: April 02, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 275273795 *Terms of Use

Device Description: Thermo-gelifiable gel for gingival preparation

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:	Yes
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?
16352	Gingival retraction kit	A collection of sterile dental instruments and other items used to hold off the gingiva during abutment preparation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MVL	Cord, Retraction

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
Weight: 1.4 Gram

Device Record Status

Public Device Record Key: 87abdf9f-668b-4502-a9a4-d1d7a88ab082
Public Version Date: April 03, 2025
Public Version Number: 3
DI Record Publish Date: September 12, 2016