Offset Cup Impactor - M10x1.5 interface 50341803

by Incipio Devices GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07630055304575 UDI-DI	Date3 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Withdrawn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 23 Oct 2026.

Specification

GUDID

Trade Name: Offset Cup Impactor - M10x1.5 interface
Generic Name: Orthopaedic implant impactor, reusable
Model / Ref / Catalog: 50341803

Primary DI / UDI-DI: 07630055304575
FDA Product Code: HWA
GMDN Term: Orthopaedic implant impactor, 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