MOBIS II Slotted mallet

by SIGNUS Medizintechnik GmbH 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	Number04047844046678 UDI-DI	Date22 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Withdrawn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: Mobis II
Generic Name: Orthopaedic surgical procedure kit, non-medicated, reusable
Model / Ref / Catalog: Slotted mallet, BZ0007

Primary DI / UDI-DI: 04047844046678
FDA Product Code: LXH
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