Drapetech
Microscope Drape for Leica M844 BIOM Compatible 46” x 60” Drawstring
9manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Guangxi (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Carl Zeiss Meditec (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Tidi Products, LLC, United States |
|---|---|
| FDA product code | EPT |
| Device type | Microscope, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4700 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-12-08 |
| Record revised | 2024-09-11 (version 8) |
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, manufacturing date |
| Packaging | Pack of 10 |
| Distribution end date | 2023-02-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28327 | Withdrawn | |
| 30057 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Jedmed | Jedmed Instrument Company | 144 |
| Seiler Medical Division | Seiler Instrument AND Manufacturing Company, Incorporated | 87 |
| Microscope | Ecleris SRL | 58 |
| M320 Optics Carrier | Leica Microsystems (Schweiz) AG | 11 |
| Microscope, Surgical | Karl Storz GmbH & Co. KG | 10 |
| BR Surgical, LLC | BR Surgical LLC | 8 |
| Vitom | Karl Storz GmbH & Co. KG | 8 |
| Quintus | Karl Storz GmbH & Co. KG | 7 |
| Extaro 300 | Carl Zeiss Meditec (Suzhou) Co., Ltd. | 6 |
| G-Series 3-STEP Microscope With 120 Degree Angled Coupler, AND Dental Composite | Global Surgical Corp. | 5 |
| G-Series 4-STEP Microscope With 120 Degree Angled Counterbalance Coupler, White | Global Surgical Corp. | 4 |
| Microcast | Karl Storz GmbH & Co. KG | 4 |
Showing 12 of 290. All products under Microscope, Surgical
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.