AccessGUDID - DEVICE: NA (04963931227556)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 22755
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 22755
Company Name: YDM CORPORATION

Primary DI Number: 04963931227556
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 716059766 *Terms of Use

Device Description: Used to tuck and direct ligatures under the archwire or bracket wings or to push archwires or auxiliaries into position, also to ligate wires.

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?
37413	Orthodontic ligature director	A hand-held dental instrument used to tuck and direct ligatures under the archwire or bracket wings or to push archwires or auxiliaries into position. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECP	Instrument, Ligature Tucking, 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: 5c608c25-4abf-4569-8eda-997b2734b7d8
Public Version Date: October 10, 2022
Public Version Number: 1
DI Record Publish Date: September 30, 2022