PureCoat
PureCoat ECM Mimetic Collagen I Peptide 100mm Dish (40 devices total in outer case)
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Trummed Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Zhejiang Saining Biotechnology Co., Ltd. | Taizhou | Zhejiang | Manufacturer | 12 |
| Zhejiang Sorfa Life Science Research Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 9 |
| Suzhou Cellpro Biotechnology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 6 |
Record
| Listed by | Corning Incorporated, United States |
|---|---|
| FDA product code | KJA |
| Device type | Flask, Tissue Culture |
| Device class | Class 1 |
| Regulation | 21 CFR 864.2240 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-15 |
| Record revised | 2022-06-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 8 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 356276 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Corning | Corning Incorporated | 432 |
| Corning® PureCoat™ | Corning Incorporated | 20 |
| Falcon | Corning Incorporated | 8 |
| Evolve | OriGen Biomedical, Inc. | 4 |
| TC Flask T75,Cell+ | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Tube 10ml 97x16PS | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Flask T75,Stand.,Vent. Cap | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Flask T175,Stand.,Vent. Cap | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Tube 12ml 99x16PS | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Flask T75,Cell+,Vented Cap | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Flask T75,Susp.,Vent. Cap | Sarstedt Aktiengesellschaft & Co.KG | 1 |
| TC Flask T25,Stand.,Vent. Cap | Sarstedt Aktiengesellschaft & Co.KG | 1 |
Showing 12 of 27. All products under Flask, Tissue Culture
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.