Orthros Mis Cm-119-04

by Camber Spine Technologies

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB030CM119040 UDI-DI	Date26 Oct 2023Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Orthros Mis
Generic name: Manual surgical rotary handpiece, reusable
Model / reference: CM-119-04

Primary DI / UDI-DI: B030CM119040
FDA product code: LXH
GMDN term: Manual surgical rotary handpiece, reusable

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

Sterilisation method: Moist Heat or Steam Sterilization

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Properties

Sterilise before use
Prescription use
Premarket exempt

Other properties (12)

Supplied sterile: No
Single use: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Lot / batch number: No
Serial number: No
Expiration date: No
Manufacturing date: No