Optics One BB3620R

by Medical Technique, Inc.

Optics One BB3620R is a Class II device made by Medical Technique, Inc., listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00815384022728), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00815384022728 UDI-DI	Date24 Sep 2016Listed	StatusListed GUDID: in commercial distribution

Official records

AccessGUDID record UDI-DI 00815384022728

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name: Optics One
Generic name: Instrument/equipment drape, single-use, sterile
Model / Ref / Catalog: BB3620R

Primary DI / UDI-DI: 00815384022728
FDA product code: KKX
GMDN term: Instrument/equipment drape, single-use, sterile

Device class: Class II
Regulation number: 878.4370
GUDID distribution status: In Commercial Distribution

Sterilisation method: Ethylene Oxide

Similar devices in this category

Other devices filed under Instrument/equipment drape, single-use, sterile.

Other devices from Medical Technique, Inc.

See all devices from Medical Technique, Inc. →

Properties

Supplied sterile
Sterilise before use
Single use
Prescription use
Premarket exempt
Lot / batch number
Expiration date

Other properties (8, all answered No)