Dolomite LZE030001

by Astura Medical

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	Number00840085242465 UDI-DI	Date28 Jul 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Dolomite
Generic Name: Orthopaedic inorganic implant inserter/extractor, reusable
Model / Ref / Catalog: LZE030001

Primary DI / UDI-DI: 00840085242465
FDA Product Code: OVE, ODP
GMDN Term: Orthopaedic inorganic implant inserter/extractor, reusable

Device Class: Class II
Regulation Number: 888.3080
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Single Use
Prescription Use
Lot / Batch Number

Other properties (11)

Sterile: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No