AccessGUDID - DEVICE: NA (04963931225101)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 22510
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22510
Company Name: YDM CORPORATION

Primary DI Number: 04963931225101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 716059766 *Terms of Use

Device Description: The intended medical indication is to use to hold or to fix or to remove small objects or to bend or to cut metal strips or wire or to cut out or make dents in several places on the resin orthodontic appliance.

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):	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?
33209	Orthodontic pliers	A hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JEX	Plier, Orthodontic

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: 23f04c5c-7b97-426b-bb6d-90c83582d771
Public Version Date: October 21, 2022
Public Version Number: 1
DI Record Publish Date: October 13, 2022