Optics ONE

Leica/Wild Microscope Drape w/angled lens 54 x 120 - with 4 oculars ..Uncoated

Registry build 21.09.26
2manufacturers in China registered for this device type
62catalogue numbers in this listing

Who Else Makes It

All of them in Jiangsu.

Chinese manufacturers registered for FDA product code HMW
Manufacturer City Province Registered as Device types
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. Siyang Jiangsu Manufacturer 21

Record

Regulatory record for Optics ONE
Listed by Medical Technique, Inc.
FDA product code HMW
Device type Drape, Microscope, Ophthalmic
Device class Class 2
Regulation 21 CFR 878.4370
Premarket notification Exempt
Record published 2016-09-23
Record revised 2018-03-29 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Ethylene Oxide
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date
Packaging Case of 2, inner pack of 5, inner pack of 10, case of 10, inner pack of 20, inner pack of 15

Catalogue Numbers

Catalogue numbers for Optics ONE
Catalogue number Size Status
4850-120GL In distribution
5950-120NS In distribution
4940-120 In distribution
5441-UC In distribution
5451-UC In distribution
5940-64GL In distribution
4850-154GL In distribution
5940-120GL In distribution
4850-120 In distribution
5950-150 In distribution
5950-62 In distribution
4701-30 In distribution
4844-120 In distribution
4718-40 In distribution
5446-UC In distribution
4850-90 In distribution
4840-105GL In distribution
4840-64GL In distribution
5452-UC In distribution
4943-62 In distribution
5920-90 In distribution
4820-90 In distribution
8910-38 In distribution
4940-62 In distribution
4820-62 In distribution
5950-90 In distribution
5950-150GL In distribution
4852-120 In distribution
5920-62 In distribution
4708-40 In distribution
5453-UC In distribution
4920-62 In distribution
M840-62NS In distribution
5909-105 In distribution
4920-90 In distribution
8902-120 In distribution
4850-120NS In distribution
4940-90 In distribution
8907-120 In distribution
4850-105GL In distribution
MTI-680 In distribution
5950-105GL In distribution
4717-40 In distribution
8907-105NR In distribution
4840-90 In distribution
5450-UC In distribution
5451-AGL In distribution
5940-105GL In distribution
4920-120 In distribution
4852-120NS In distribution
5940-62 In distribution
5940-120 In distribution
M840-90 In distribution
5940-90 In distribution
5440-UC In distribution
4840-120 In distribution
4840-62 In distribution
4840-120GL In distribution
5950-120GL In distribution
8907-62NR In distribution
M840-62 In distribution
5950-120 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
V. Mueller Carefusion 2200, Inc. 3
Adler Instrument Company Adler, Inc. 2
Exact Medical Manufacturing, Inc. Exact Medical Manufacturing, Inc. 2
Sterilizable Metal Sleeve Carl Zeiss Meditec Inc 1
2-Pack Asepsis Visulux Carl Zeiss Meditec Inc 1
SpandaGrip Medi-Tech, Inc. 1
Drape, Microscope, Ophthalmic Karl Storz GmbH & Co. KG 1
Vashe Sterile Sleeve Urgo Medical North America, LLC 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer