AccessGUDID - DEVICE: Stainless Steel (D78866021200151)

GUDID

Device Identifier (DI) Information

Brand Name: Stainless Steel
Version or Model: 66-0212-0015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 66-0212-0015
Company Name: Gc Orthodontics America Inc.

Primary DI Number: D78866021200151
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 063167128 *Terms of Use

Device Description: Surgical Ball Hook .022 Pack of 10

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?
63379	Orthodontic power arm/lock	An orthodontic device in the shape of a straight pin or hook designed to accept an elastic band, power chain, spring, or archwire (not included), which apply a force in addition to the main orthodontic archwire, for vertical alignment and/or horizontal positioning of the teeth; it also includes a base that functions as an orthodontic lock/stop. The device is crimped, soldered or screwed on an orthodontic attachment (e.g., bracket, archwire) or the surface of a tooth. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ECN	CLAMP, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1607f9db-568b-46c0-b5f7-a07e323cdbfe
Public Version Date: August 31, 2021
Public Version Number: 1
DI Record Publish Date: August 23, 2021