AccessGUDID - DEVICE: M5 TRUEFORM THERMAL NICKEL TITANIUM SOLO-PACK (10190886181058)

GUDID

Device Identifier (DI) Information

Brand Name: M5 TRUEFORM THERMAL NICKEL TITANIUM SOLO-PACK
Version or Model: M5TFL1625AS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: G & H Wire Company, Inc.

Primary DI Number: 10190886181058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831465641 *Terms of Use

Device Description: M5 THERMAL Cu NITI TFI LWR 016X025 SOLO PACK

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?
41397	Orthodontic archwire	A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZC	WIRE, 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
Height: .016 Inch
Width: .025 Inch

Device Record Status

Public Device Record Key: fc5bb3b5-1802-4dcc-8546-4dce9d3041d1
Public Version Date: April 03, 2025
Public Version Number: 1
DI Record Publish Date: March 26, 2025