AccessGUDID - DEVICE: Kobayashi Tie Hooks (D798K141)

GUDID

Device Identifier (DI) Information

Brand Name: Kobayashi Tie Hooks
Version or Model: K14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K14
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798K141
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: Kobayashi Tie Hooks are Intended for the use of ligating archwires and hooks to orthodontic brackets and elastics. Size 0.014 Kobayashi Tie Hooks

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):	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?
41677	Orthodontic archwire/bracket ligature	A device intended to securely tether an orthodontic archwire to an orthodontic bracket, or securely hold the archwire in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie, or a circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZC	Wire, 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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at ambient conditions.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f4739900-0cb6-433d-8ef2-cb258a889b93
Public Version Date: June 22, 2021
Public Version Number: 3
DI Record Publish Date: August 06, 2016