AccessGUDID - DEVICE: ORTHOMETRIC BANDS (07908470700747)

GUDID

Device Identifier (DI) Information

Brand Name: ORTHOMETRIC BANDS
Version or Model: 40.02.0355
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40.02.0355
Company Name: ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Primary DI Number: 07908470700747
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 898330003 *Terms of Use

Device Description: ORTHODONTIC BANDS- UPPER 35,5 MM

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?
46338	Orthodontic band material	A material typically supplied in the form of rolls, strips, or precut blanks with the attachments in place ready to be configured as orthodontic bands. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYO	Band, Material, 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: 526cfcc1-018a-4e9b-8aa3-5848a0897bfc
Public Version Date: October 06, 2022
Public Version Number: 1
DI Record Publish Date: September 28, 2022