Sirion GZC13B16D

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	Number00841379194989 UDI-DI	Date15 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Withdrawn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: Spinal implant trial
Model / Ref / Catalog: GZC13B16D

Primary DI / UDI-DI: 00841379194989
FDA Product Code: OVD, KWQ, MAX
GMDN Term: Spinal implant trial

Device Class: Class II
Regulation Number: 888.3080, 888.3060
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

Size: Width — 20 Millimeter
Height — 16 Millimeter
Angle — 15 degree

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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