Isola 205046

by Depuy Spine, Inc.

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	Number10705034001401 UDI-DI	Date31 Dec 2016Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 10705034001401

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Isola
Generic name: Abdominal/ENT/orthopaedic surgical probe, reusable
Model / Ref / Catalog: 205046

Primary DI / UDI-DI: 10705034001401
FDA product code: HXB
GMDN term: Abdominal/ENT/orthopaedic surgical probe, 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
Lot / batch number

Other properties (11)

Supplied 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
Manufacturing date: No