Sirion GZA08A110

by Astura Medical GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00840085203473 UDI-DI	Date12 Jul 2021Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name: Sirion
Generic Name: Surgical retractor/retraction system blade, reusable
Model / Ref / Catalog: GZA08A110

Primary DI / UDI-DI: 00840085203473
FDA Product Code: KWQ
GMDN Term: Surgical retractor/retraction system blade, reusable

Device Class: Class II
Regulation Number: 888.3060
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Size: Length — 110 Millimeter
Width — 13 Millimeter

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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