AccessGUDID - DEVICE: InBrace Teeth Straightening System (Gen 2.0) (00850018135054)

GUDID

Device Identifier (DI) Information

Brand Name: InBrace Teeth Straightening System (Gen 2.0)
Version or Model: Lower Fitting Kit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 85003
Company Name: SWIFT HEALTH SYSTEMS INC.

Primary DI Number: 00850018135054
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 884398210 *Terms of Use

Device Description: No description.

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?
64010	Orthodontic appliance/positioning tray kit	A collection of dental devices which includes a custom-made positioning tray (indirect bonding tray) intended to position and hold in place a set of included orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) to bond them to teeth during a single procedure. The components are typically made of synthetic polymer and/or metal materials and include appliances manufactured from an oral cavity impression or oral scan for a specific patient (custom-made). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PNN	Orthodontic Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: b15e1541-b71c-4949-b462-b5f881efac5b
Public Version Date: October 04, 2022
Public Version Number: 2
DI Record Publish Date: November 07, 2021