AccessGUDID - DEVICE: Power Hook (00190746074646)

GUDID

Device Identifier (DI) Information

Brand Name: Power Hook
Version or Model: 855-272
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 855-272
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746074646
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: POWER HOOK TRIPLE CAST SLIDE ON 018 LENGTH= 4MM, 7MM, AND 11MM 10/PKG

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
31797	Orthodontic spring	A dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.	Active	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: 6bfba9fd-d97e-49a4-b0b2-9cf72b55a643
Public Version Date: December 31, 2024
Public Version Number: 3
DI Record Publish Date: June 24, 2019