AccessGUDID - DEVICE: ELAS-O-LOOP (D90927020917)

GUDID

Device Identifier (DI) Information

Brand Name: ELAS-O-LOOP
Version or Model: 270-209
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 270-209
Company Name: Ortho Arch Company Inc

Primary DI Number: D90927020917
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020956330 *Terms of Use

Device Description: ELAS-O-LOOP DB HOOK (10)

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?
44732	Orthodontic aligner auxiliary attachment kit	A collection of devices, used with retainer-style orthodontic appliances (e.g., preformed teeth aligners) to further facilitate and enhance teeth alignment. The kit includes buttons and elastics, typically made of clear materials for aesthetic purposes, that are attached to the orthodontic aligner and/or teeth to help achieve extrusion, rotation and anchorage control. This provides the clinician with greater control to achieve additional tooth movement during the treatment. The contents of this kit may also include plastic/composite adhesive, etchant, elastics, burs and polishing wheels for cutting the aligners. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ECQ	Aligner, Bracket, 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: 47b4d3ef-4a78-4228-8ae6-3ce8c6ca6eef
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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