AccessGUDID - DEVICE: ORTHOMETRIC ELASTOMERICS

GUDID

Device Identifier (DI) Information

Brand Name: ORTHOMETRIC ELASTOMERICS - CHAIN
Version or Model: 60.05.5022
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60.05.5022
Company Name: ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Primary DI Number: 07908470702925
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 898330003 *Terms of Use

Device Description: ORTHOMETRIC ELASTOMERICS- ELASTIC CHAIN 1,5M- SHORT- CRYSTAL RED

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?
62074	Orthodontic inter-arch elastic band	A non-sterile circular band intended to be used during orthodontic treatment to exert a continuous light force to adjust bite and jaw position for correcting malocclusions (e.g., overbite, underbite). It is made of an elastomeric material (e.g., polyurethane, rubber) and is secured to hooks on orthodontic brackets across non-opposing mandibular and maxillary teeth. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).	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: 93b3826b-8ebe-409f-a0b2-59147c8c3947
Public Version Date: October 07, 2022
Public Version Number: 1
DI Record Publish Date: September 29, 2022