Tissue-Tek® Glas™ G2
Coverslips 24 x 60 mm; 200 coverslips; 5 holders/case
32manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (11), Jiangsu (10), Shanghai (7). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Epredia Laboratory Products Manufacturing (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
Showing 12 of 32. All 32 manufacturers in China registered for Coverslips, Microscope Slide
Record
| Listed by | Sakura Finetek U.S.A., Inc., United States |
|---|---|
| FDA product code | KES |
| Device type | Coverslips, Microscope Slide |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3010 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-02-06 |
| Record revised | 2020-08-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6417 | In distribution | |
| 6416 | In distribution | |
| 6415 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Marienfeld Superior | Paul Marienfeld Gmbh & Co. KG. | 585 |
| Epredia | NEW Erie Scientific LLC | 280 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 105 |
| Globe Scientific | Globe Scientific, LLC | 27 |
| Microscope Cover Glass | Typenex Medical, LLC | 26 |
| Leica Biosystems | Leica Biosystems Richmond, Inc. | 17 |
| Tanner | Yancheng Jingwei Chemicals Co., Ltd. | 13 |
| Hareta | Yancheng Jingwei Chemicals Co., Ltd. | 9 |
| Rankin | Yancheng Jingwei Chemicals Co., Ltd. | 8 |
| Pathsuplly | Yancheng Jingwei Chemicals Co., Ltd. | 8 |
| McKesson | Mckesson Medical-Surgical Inc. | 4 |
| N/A (Approved Vendor) | Grainger International, Inc. | 3 |
Showing 12 of 21. All products under Coverslips, Microscope Slide
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K882881 | 1988-07-28 |
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.