Medical Action Industries
Ndlctr: Foam Strip/Foam Strip 30Ct 168Cs
105manufacturers in China registered for this device type
108catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 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 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument
Record
| Listed by | Medical Action Industries, Inc., United States |
|---|---|
| FDA product code | FSM |
| Device type | Tray, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2016-08-20 |
| Record revised | 2024-06-03 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: store at room temperature |
| Packaging | Pack of 4, pack of 16, pack of 8, pack of 21, pack of 12, pack of 48 |
| Distribution end date | 2024-05-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2102 | In distribution | ||
| 9105 | In distribution | ||
| NS5103 | 192 | In distribution | |
| 6704 | 300 | In distribution | |
| NS2206 | 192 | In distribution | |
| 5107 | In distribution | ||
| 9220 | In distribution | ||
| 2109 | In distribution | ||
| 5101 | In distribution | ||
| 9108 | In distribution | ||
| NS2108 | 192 | In distribution | |
| NS2106 | 192 | In distribution | |
| NS5106 | 192 | In distribution | |
| 2106 | In distribution | ||
| NS9220 | 96 | In distribution | |
| 2104 | In distribution | ||
| NS9020 | 96 | In distribution | |
| 9030 | In distribution | ||
| 5106 | In distribution | ||
| NS9606 | 96 | In distribution | |
| NS9210 | 200 | In distribution | |
| 9101 | In distribution | ||
| NS9107 | 96 | In distribution | |
| 2108 | In distribution | ||
| 4102 | In distribution | ||
| NS9104 | 96 | In distribution | |
| NS9103 | 96 | In distribution | |
| 4103 | In distribution | ||
| NS9030 | 96 | In distribution | |
| 2105 | In distribution | ||
| 9040 | In distribution | ||
| 9102 | In distribution | ||
| 9106 | In distribution | ||
| NS2203 | 340 | In distribution | |
| NS4101 | 340 | In distribution | |
| 4101 | In distribution | ||
| NS2104 | 340 | In distribution | |
| 9103BR | In distribution | ||
| 9020 | In distribution | ||
| 2206 | In distribution | ||
| NS9108 | 96 | In distribution | |
| 9107 | In distribution | ||
| NS9110 | 96 | In distribution | |
| NS9106 | 96 | In distribution | |
| NS9105 | 200 | In distribution | |
| 9110 | In distribution | ||
| 2100 | In distribution | ||
| 5103 | In distribution | ||
| 5100 | In distribution | ||
| NS2101 | 340 | In distribution | |
| NS5107 | 192 | In distribution | |
| 2101 | In distribution | ||
| 2103 | In distribution | ||
| NS9102 | 96 | In distribution | |
| 9104 | In distribution | ||
| NS5100 | 192 | In distribution | |
| NS9010 | 200 | In distribution | |
| NS5101 | 340 | In distribution | |
| 9010 | In distribution | ||
| NS2105 | 192 | In distribution | |
| NS2102 | 340 | In distribution | |
| NS4103 | 192 | In distribution | |
| 9103 | In distribution | ||
| NS9101 | 200 | In distribution | |
| NS2109 | 192 | In distribution | |
| NS4102 | 192 | In distribution | |
| NS9040 | 96 | In distribution | |
| NS2103 | 340 | In distribution | |
| NS2100 | 340 | In distribution | |
| NS5102 | 340 | In distribution | |
| NS2110 | 340 | In distribution | |
| 6218-1 | 150 | Withdrawn | |
| 6705 | 180 | Withdrawn | |
| 6005-1 | 175 | Withdrawn | |
| 6005 | 50 | Withdrawn | |
| 6805-1 | 175 | Withdrawn | |
| 6206 | 25 | Withdrawn | |
| 200-16A | Withdrawn | ||
| 6216 | 15 | Withdrawn | |
| 6110 | 40 | Withdrawn | |
| 6010 | 50 | Withdrawn | |
| NS9109 | 96 | Withdrawn | |
| 6067 | 75 | Withdrawn | |
| 100-10A | Withdrawn | ||
| 6060 | 8 | Withdrawn | |
| 6071 | 75 | Withdrawn | |
| 2110 | Withdrawn | ||
| 6203 | 40 | Withdrawn | |
| 200-20A | Withdrawn | ||
| 6830 | 8 | Withdrawn | |
| 6110-1 | 150 | Withdrawn | |
| 2102BR | Withdrawn | ||
| 2203 | Withdrawn | ||
| 6810-1 | 350 | Withdrawn | |
| 6010-1 | 350 | Withdrawn | |
| 6218 | 15 | Withdrawn | |
| 9102BR | Withdrawn | ||
| 6805 | 50 | Withdrawn | |
| 6069 | 75 | Withdrawn | |
| 6105 | 250 | Withdrawn | |
| 6141 | 250 | Withdrawn | |
| 6810 | 50 | Withdrawn | |
| 6860 | 8 | Withdrawn | |
| 5102 | Withdrawn | ||
| 6070 | 75 | Withdrawn | |
| 9109 | Withdrawn | ||
| 6030 | 8 | Withdrawn | |
| 6106 | 250 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IMS | HU-Friedy MFG Co., LLC | 2,710 |
| Tray, Surgical, Instrument | Synthes Gmbh | 1,052 |
| Tray, Surgical, Instrument | Medtronic Sofamor Danek, Inc. | 1,012 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 666 |
| Aptus | Medartis Inc. | 588 |
| Acumed | Acumed LLC | 566 |
| Aesculap | Aesculap AG | 532 |
| Sklar | Sklar Corporation | 465 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 438 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 429 |
| Level ONE | KLS-Martin L.P. | 341 |
| Bahadir USA | Bahadir USA LLC | 300 |
Showing 12 of 3,212. All products under Tray, Surgical, Instrument
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medical Action Industries, Inc. 306 | UDI-DI | 2024-06-11 | Class II | Under Investigation by firm | The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foam pouches were misused due to misclassification of the GMDN. | 5,981,534 units |
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.