AccessGUDID - DEVICE: HALO MOLAR BAND (D909901902L1)

GUDID

Device Identifier (DI) Information

Brand Name: HALO MOLAR BAND
Version or Model: L6R MOLAR BAND .022 0T BT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 901-902L
Company Name: Ortho Arch Company Inc

Primary DI Number: D909901902L1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020956330 *Terms of Use

Device Description: L6R HALO MOLAR BAND .022 SGL CV 0T BT

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?
38734	Orthodontic metal band	A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECI	Band, Elastic, 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: 7b081b1e-3e87-4684-9412-f1a0d51df81e
Public Version Date: October 31, 2022
Public Version Number: 1
DI Record Publish Date: October 21, 2022