MIS Bunion Accessory Kit (47-0028-S) 1032-001

by Eca Medical Instruments 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	Number00850078396013 UDI-DI	Date11 Nov 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Withdrawn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 22 Oct 2026.

Specification

GUDID

Trade Name: MIS Bunion Accessory Kit (47-0028-S)
Generic Name: Orthopaedic surgical procedure kit, non-medicated, single-use
Model / Ref / Catalog: 1032-001

Primary DI / UDI-DI: 00850078396013
FDA Product Code: LXH
GMDN Term: Orthopaedic surgical procedure kit, non-medicated, single-use

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

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Properties

Sterile
Single Use
Prescription Use
Convenience Kit
Premarket Exempt
Lot / Batch Number
Expiration Date
Manufacturing Date

Other properties (6)

Implantable: No
Contains Latex: No
Over-the-Counter: No
Combination Product: No
HCT/P: No
Serial Number: No