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Roi-A IR92002R

by Ldr Spine USA

Roi-A IR92002R is a Class II device made by Ldr Spine USA, listed in FDA GUDID since 23 Mar 2017 (UDI-DI 03662663022668), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03662663022668 UDI-DI Date23 Mar 2017ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Roi-A
Generic name
Chisel/osteotome blade handle
Model / Ref / Catalog
IR92002R
Primary DI / UDI-DI
03662663022668
FDA product code
OVD
GMDN term
Chisel/osteotome blade handle
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Chisel/osteotome blade handle

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Other devices filed under Chisel/osteotome blade handle.

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Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)