AccessGUDID - DEVICE: Orthoquest (00840326408841)

GUDID

Device Identifier (DI) Information

Brand Name: Orthoquest
Version or Model: G198
Commercial Distribution Status: In Commercial Distribution
Catalog Number: G198
Company Name: Young Innovations, Inc.

Primary DI Number: 00840326408841
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004193103 *Terms of Use

Device Description: REPLACEMENT PADS FOR G008 1/4in

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?
62642	Medical device wiping pad	A small non-sterile pad made of absorbent material intended as a convenient means of wiping debris from a surgical/dental instrument during a procedure, having an adhesive surface so that it may be fixed to a glove, drape or other medical device. It does not contain a medication. This is a single-use device that may be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZN	INSTRUMENTS, DENTAL HAND

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: 5416b911-b16a-4fc2-8064-be297b85550e
Public Version Date: November 11, 2022
Public Version Number: 1
DI Record Publish Date: November 03, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10840326408848	6	00840326408841		In Commercial Distribution	Inner

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1 (800) 558-6684
Email: support@youngspecialties.com

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