Gynescope single use vaginal speculum size large 60 units 01

by Illumigyn, Ltd.

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	Number47290018240012 UDI-DI	Date25 Sep 2020Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Gynescope single use vaginal speculum size large 60 units
Generic Name: Video colposcope speculum
Model / Ref / Catalog: 01, IL-100-200-410

Primary DI / UDI-DI: 47290018240012
FDA Product Code: HIB
GMDN Term: Video colposcope speculum

Device Class: Class II
Regulation Number: 884.4530
GUDID distribution status: In Commercial Distribution

MRI Safety: MR Unsafe

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Properties

Single Use
Prescription Use
Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (9)

Sterile: 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