AccessGUDID - DEVICE: Hanks Telescoping Herbst (00190746151552)

GUDID

Device Identifier (DI) Information

Brand Name: Hanks Telescoping Herbst
Version or Model: 855-735PK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 855-735PK
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746151552
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: HTH/MINISCOPE APPLE CORE SCREW LONG 50/PK

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?
65804	Orthodontic rod-based aligner	An orthodontic device which includes a rod(s) intended to be bonded to teeth to correct malocclusions (e.g., overbites); it is commonly known as Herbst appliance. The rod, also referred to as a piston or tube, is typically positioned with a metal band and/or bracket and incorporates a hinge-like mechanism to allow jaw opening/closing. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYJ	RETAINER, SCREW EXPANSION, 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: e4cbebc8-f206-4115-8f20-5c2d4a96742f
Public Version Date: January 24, 2025
Public Version Number: 4
DI Record Publish Date: March 16, 2020