INSTRUMENT Plate bender

by SIGNUS Medizintechnik GmbH GUDID 3 variants

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04047844047507 UDI-DI	Date30 Jun 2022Listed	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Withdrawn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 22 Oct 2026.

Specification

GUDID

Trade Name: Instrument
Generic Name: Orthopaedic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog: Plate bender, DZ-1001-A

Primary DI / UDI-DI: 04047844047507
FDA Product Code: HXW
GMDN Term: Orthopaedic surgical procedure kit, non-medicated, reusable

Device Class: Class I
Regulation Number: 888.4540
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Prescription Use
Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (10)

Sterile: No
Single Use: 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