AccessGUDID - DEVICE: GLIDE CHAIN ELASTIC (D90930040700)

GUDID

Device Identifier (DI) Information

Brand Name: GLIDE CHAIN ELASTIC
Version or Model: 300-407
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 300-407
Company Name: Ortho Arch Company Inc

Primary DI Number: D90930040700
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020956330 *Terms of Use

Device Description: GLIDE CHAIN ELASTIC LONG ROYAL BLUE 15' 15'

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?
62073	Orthodontic inter-bracket elastic chain	A non-sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). 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: f728becc-9d65-4246-b94c-5f267eee0229
Public Version Date: September 20, 2021
Public Version Number: 2
DI Record Publish Date: September 01, 2021