Integra®
Trapsystem® Regular Bone Marrow Biopsy / Aspiration Tray
60manufacturers in China registered for this device type
77catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston
Record
| Listed by | Integra Pain Management, United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K960248 |
| Record published | 2018-06-20 |
| Record revised | 2023-12-05 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 68 to 77 °F; Storage environment temperature 20 to 25 °C; Special storage condition: Do Not Use if Package is Damaged |
| Packaging | Case of 10, case of 20, case of 5 |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-2558 | Withdrawn | |
| SS3290 | Withdrawn | |
| 3404514-IMA | Withdrawn | |
| CUS1207-01 | Withdrawn | |
| CUS1025 | Withdrawn | |
| 3805428 | Withdrawn | |
| 3405340 | Withdrawn | |
| TRAPJTD1110-15-IMA | Withdrawn | |
| CUS1765-01 | Withdrawn | |
| 3403904-3 | Withdrawn | |
| 3605424 | Withdrawn | |
| CUS494 | Withdrawn | |
| CUS1173 | Withdrawn | |
| CUS1761 | Withdrawn | |
| 3403133 | Withdrawn | |
| 3403958 | Withdrawn | |
| 3405386 | Withdrawn | |
| 3405230 | Withdrawn | |
| BMTX-1047 | Withdrawn | |
| 3405375 | Withdrawn | |
| CUS1443-02 | Withdrawn | |
| 3405339 | Withdrawn | |
| 3405392 | Withdrawn | |
| 3405276 | Withdrawn | |
| 3405185 | Withdrawn | |
| 3405226 | Withdrawn | |
| 13-2492 | Withdrawn | |
| CUS1539-07 | Withdrawn | |
| 3405034 | Withdrawn | |
| 3405410 | Withdrawn | |
| 3405364 | Withdrawn | |
| 3805394 | Withdrawn | |
| TRAPJTD1110-15 | Withdrawn | |
| CUS144-01 | Withdrawn | |
| CUS1122 | Withdrawn | |
| CUS312 | Withdrawn | |
| CUS1318-01 | Withdrawn | |
| 13-2520 | Withdrawn | |
| CUS1871 | Withdrawn | |
| 3403356 | Withdrawn | |
| CUS1119-01 | Withdrawn | |
| 3405062 | Withdrawn | |
| SS3209 | Withdrawn | |
| 3405333 | Withdrawn | |
| CUS772 | Withdrawn | |
| 3403081 | Withdrawn | |
| 3405298 | Withdrawn | |
| 3405144 | Withdrawn | |
| 3805354 | Withdrawn | |
| CUS1367-02 | Withdrawn | |
| 3405419 | Withdrawn | |
| CUS290 | Withdrawn | |
| 3404892 | Withdrawn | |
| 3403134 | Withdrawn | |
| CTD1110/1510-IMA | Withdrawn | |
| 3405413 | Withdrawn | |
| 3405405 | Withdrawn | |
| CUS265-01 | Withdrawn | |
| CUS445 | Withdrawn | |
| CUS1174 | Withdrawn | |
| 3805415 | Withdrawn | |
| 3404931 | Withdrawn | |
| 3805412 | Withdrawn | |
| 3405366 | Withdrawn | |
| 3404922-1 | Withdrawn | |
| SS3157 | Withdrawn | |
| 3404697 | Withdrawn | |
| 3404441 | Withdrawn | |
| CUS1111-01 | Withdrawn | |
| TRAPJT1110-IMA | Withdrawn | |
| 3805411 | Withdrawn | |
| 3405432 | Withdrawn | |
| 3405348 | Withdrawn | |
| 3405224 | Withdrawn | |
| 3405382 | Withdrawn | |
| 3805430-IMA | Withdrawn | |
| CUS526 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 228 |
| Medallion® | Merit Medical Systems, Inc. | 223 |
| Merit Medical® | Merit Medical Systems, Inc. | 192 |
| Monoject | Cardinal Health | 188 |
| Medline | Medline Industries, Inc. | 127 |
| EasyTouch | MHC Medical Products | 122 |
| Medline Industries, Inc. | Medline Industries, Inc. | 99 |
| Arrow | Teleflex Medical LLC | 94 |
| Ceros | Rhino Medical Supply Inc | 92 |
| Enteral Feeding | Medela LLC | 87 |
| Monoject | Cardinal Health 200, LLC | 83 |
| HSW Soft-Ject® | Henke-Sass Wolf, Gmbh. | 80 |
Showing 12 of 913. All products under Syringe, Piston
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Pain Management | 510(k) number | 2015-09-22 | Class II | Process control | Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1% Lidocaine HCL Injection, USP, 10 mg/mLm distributed by | A total of 470 packages (47 cases) | 2016-01-29 |
| Integra Lifesciences Corporation | 510(k) number | 2011-05-19 | Not classified | Nonconforming Material/Component | Kits contain protective wipes that may be contaminated with Bacillus cereus. | 520 kits | 2011-08-01 |
| Integra Lifesciences Corporation | 510(k) number | 2011-05-19 | Not classified | Nonconforming Material/Component | Kits contain protective wipes that may be contaminated with Bacillus cereus. | 40 kits | 2011-08-01 |
| Integra Pain Management | 510(k) number | 2008-03-18 | Not classified | Nonconforming Material/Component | Hep-Lock Flush vials included in Integra’s PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin. | 500 kits | 2008-11-05 |
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.