AccessGUDID - DEVICE: Young (00302731777016)

GUDID

Device Identifier (DI) Information

Brand Name: Young
Version or Model: 177701
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 177701
Company Name: YOUNG DENTAL MANUFACTURING I, LLC

Primary DI Number: 00302731777016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006309355 *Terms of Use

Device Description: Young Rubber Damn Frame Kit, Contoured Adult, Hooks, Balls, 7 tines,(5 1/16 in. X 4 1/8 in.) (12.8 cm x 10.4 cm), neckbands, template and manual

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?
31849	Rubber dam frame	A flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJE	FRAME, RUBBER DAM

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: c1909848-e5a3-4fd4-97fd-f0e78e4adf81
Public Version Date: October 24, 2022
Public Version Number: 1
DI Record Publish Date: October 16, 2022