Exact Medical Manufacturing, Inc.
Microscope Drape, Leica 137x381cm – 54” x 150”
2manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu.
| 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
| Listed by | Exact Medical Manufacturing, Inc., China |
|---|---|
| FDA product code | HMW |
| Device type | Drape, Microscope, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-10-24 |
| Record revised | 2024-10-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case, inner case of 16, inner case of 10 |
| Distribution end date | 2024-10-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EP5513 | Withdrawn | |
| EP5512 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optics ONE | Medical Technique, Inc. | 62 |
| V. Mueller | Carefusion 2200, Inc. | 3 |
| Adler Instrument Company | Adler, 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.