Micromat®
Microsurgical Grid Background Material Without Suction Grid - Yellow
5manufacturers in China registered for this device type
9catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Keling Medical Appliances Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 23 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Shandong Kangli Medical Equipment Technology Co., Ltd. | Zaozhuang | Shandong | Manufacturer | 23 |
| Wuhan Huaxin Nonwoven Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 13 |
Record
| Listed by | PMT Corp., United States |
|---|---|
| FDA product code | FNW |
| Device type | Pad, Kelly |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K831117 |
| Record published | 2016-08-01 |
| Record revised | 2018-05-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 58 to 78 °F |
| Packaging | Pack of 12 |
| Sizes | Catheter gauge 3 to 7 Fr; width 2.4 cm; length 5.25 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3103-3G-WO | Catheter Gauge 3 Fr | In distribution |
| 3103-5G-Y | Catheter Gauge 5 Fr | In distribution |
| 3105-M-Y-12 | In distribution | |
| 3103-7G-WO | Catheter Gauge 7 Fr | In distribution |
| 3105-G | Width 2.4 cm | In distribution |
| 3103-5G-Y-WO | Catheter Gauge 5 Fr | In distribution |
| 3105-G-Y | Width 2.4 cm | In distribution |
| 3103-7G | Catheter Gauge 7 Fr | In distribution |
| 3105-M-B-12 | In distribution |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K831117 | 1984-05-30 |
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.