Sterilizable Metal Sleeve
Catalogue number 000000-0140-600, listed by Carl Zeiss Meditec Inc, United States, under Drape, Microscope, Ophthalmic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
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 | Carl Zeiss Meditec Inc, United States |
|---|---|
| FDA product code | HMW |
| Device type | Drape, Microscope, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-05-04 |
| Record revised | 2024-09-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 2 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000000-0140-600 | In distribution |
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 |
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 2 |
| 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.