Trueform Solo-Pack CUTFU012S

by G&H Wire Company, Inc. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10190886012420 UDI-DI	Date26 Mar 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name: Trueform Solo-Pack
Generic Name: Orthodontic archwire
Model / Reference: CUTFU012S

Primary DI / UDI-DI: 10190886012420
FDA Product Code: DZC
GMDN Term: Orthodontic archwire

Device Class: Class I
Regulation Number: 872.5410
GUDID distribution status: In Commercial Distribution

Size: Outer Diameter — .012 Inch

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Properties

Single Use
Prescription Use
Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (9)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No