Olympic AZE070550

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	Number00841379165453 UDI-DI	Date2 Jun 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Olympic
Generic Name: Peripheral vascular guidewire, manual
Model / Ref / Catalog: AZE070550

Primary DI / UDI-DI: 00841379165453
FDA Product Code: LXH, OLO, NKB, KWP
GMDN Term: Peripheral vascular guidewire, manual

Device Class: Class I
Regulation Number: 888.4540, 882.4560, 888.3070, 888.3050
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Size: Guidewire Diameter — 1.4 Millimeter
Guidewire Length — 550 Millimeter

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Properties

Prescription Use
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: 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