StabiliT®
24 catalogue numbers from 00884450492369, listed by Merit Medical Systems, Inc., United States, under Instrument, Manual, Surgical, General Use. 110 manufacturers in China are registered for this product code.
110manufacturers in China registered for this device type
24catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (31), Jiangsu (27), Guangdong (20). 29 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 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
Showing 12 of 110. All 110 manufacturers in China registered for Instrument, Manual, Surgical, General Use
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | MDM |
| Device type | Instrument, Manual, Surgical, General Use |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-08-30 |
| Record revised | 2025-04-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 30, pack of 75, pack of 22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 00884450492369 | Size-Long | In distribution | |
| 00884450390467 | Gauge-10G | In distribution | |
| 00884450374337 | Tip Type-Bevel | In distribution | |
| 00884450724804 | Tip Type-Trocar | In distribution | |
| 00884450390450 | Gauge-10G | In distribution | |
| 00884450390443 | Size-Short | In distribution | |
| 00884450469057 | Size-Long | In distribution | |
| 00884450390474 | Size-Short | In distribution | |
| 00884450492376 | Length-10.0 cm | In distribution | |
| 00884450296219 | Gauge-10G | In distribution | |
| 00884450296240 | Size-Short | In distribution | |
| 00884450724798 | Tip Type-Bevel | In distribution | |
| 00884450469088 | Size-Short | In distribution | |
| 00884450296226 | Gauge-10G | In distribution | |
| A | Length-12.0 cm | In distribution | |
| A | Length-12.0 cm | In distribution | |
| G | Size-Long | 75 | In distribution |
| G | Tip Type-Trocar | 75 | In distribution |
| 00884450469064 | In distribution | ||
| F | Length-10.0 cm | In distribution | |
| 00884450296417 | Gauge-10/11G | In distribution | |
| 10884450492359 | Gauge-10G | 75 | In distribution |
| 00884450296233 | Size-Short | In distribution | |
| 00884450374344 | Gauge-10G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 1,686 |
| TSI | Tedan Surgical Innovations, L.L.C. | 1,181 |
| Medfix | Medfix International, LLC | 514 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 446 |
| Fentex | Fentex medical GmbH | 407 |
| Millennium | Avalign Technologies, Inc. | 337 |
| Synergetics | Synergetics USA, Inc. | 312 |
| American Medicals | American Medicals | 298 |
| gSource | Gsource, LLC. | 291 |
| Life Instruments | Life Instrument Corp. | 274 |
| Ambler Surgical | Ambler Surgical, LLC | 272 |
| Instrument, Manual, Surgical, General Use | Karl Storz GmbH & Co. KG | 261 |
Showing 12 of 1,364. All products under Instrument, Manual, Surgical, General Use
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-09-29 | Not classified | Other | Potential sterility breach caused by excessive shipment damage. | 30 kits | 2009-12-15 |
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.