AccessGUDID - DEVICE: AURADONICS (00810033834288)

GUDID

Device Identifier (DI) Information

Brand Name: AURADONICS
Version or Model: 700-534 7.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AURADONICS INC.

Primary DI Number: 00810033834288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 608537379 *Terms of Use

Device Description: CHAIN CONT - CORAL, 7.5 FT each, see www.auradonics.com

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
Special Storage Condition, Specify: Away from sunlight or strong light
Storage Environment Temperature: between 6 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6385aaa2-3f24-43f1-9db1-6a73f213a365
Public Version Date: January 07, 2020
Public Version Number: 1
DI Record Publish Date: December 30, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8567648866
Email: auradonics@aol.com

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