AccessGUDID - DEVICE: REVOTEK LC™ (14548161062084)

GUDID

Device Identifier (DI) Information

Brand Name: REVOTEK LC™
Version or Model: 001842
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001842
Company Name: Gc America Inc.

Primary DI Number: 14548161062084
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: REVOTEK LC™ Intro Package, B2 (1 x Putty Stick, 1 x Lightproof storage case, 1 x GC Spatula N° 2)

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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBH	VARNISH, CAVITY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012542	000

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
Storage Environment Temperature: between 20 and 25 Degrees Celsius
Storage Environment Temperature: between 68 and 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 46ad70fd-769d-4bb9-9d2f-4bb1cc8e3071
Public Version Date: August 15, 2022
Public Version Number: 1
DI Record Publish Date: August 05, 2022