MSI
Caspar IVD Rongeur 7 1/4” straight Fenestrated jaw, serrated cup, 2 X 12mm Bite
11manufacturers in China registered for this device type
109catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (5), Shandong (3), Jiangsu (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Changzhou Geasure Medical Apparatus AND Instruments Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 25 |
| Qingdao Zhixing Medical Instrument Co., Ltd. | Qingdao | Shandong | Manufacturer | 6 |
Record
| Listed by | Modern Surgical Instruments LLC, United States |
|---|---|
| FDA product code | HTX |
| Device type | Rongeur |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2022-08-02 |
| Record revised | 2023-02-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2023-02-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71-2456 | In distribution | |
| 55-0858 | In distribution | |
| 47-0702 | In distribution | |
| 57-2834 | In distribution | |
| 66.6256 | In distribution | |
| 57.30.31 | In distribution | |
| 47-0688 | In distribution | |
| 57.30.35 | In distribution | |
| 57.30.35 | In distribution | |
| 47-0524 | In distribution | |
| 71-2399 | In distribution | |
| 55-0691 | In distribution | |
| 71-2436 | In distribution | |
| MSI 47-0858 | In distribution | |
| 47-0730 | In distribution | |
| 68.9536 | In distribution | |
| 990.06.96 | In distribution | |
| 55-0960 | In distribution | |
| 55-0690 | In distribution | |
| 47-0840 | In distribution | |
| 57.27.92 | In distribution | |
| 47-0858 | In distribution | |
| 57.28.32 | In distribution | |
| 47-0487 | In distribution | |
| 57.28.36 | In distribution | |
| 70.1330 | In distribution | |
| 57-0694BD-H | In distribution | |
| 57.30.32 | In distribution | |
| 68.9532 | In distribution | |
| 57-0695BD-H | In distribution | |
| 55-0963 | In distribution | |
| 66.6600 | In distribution | |
| 57-2835 | In distribution | |
| 71-2977 | In distribution | |
| 47-0492 | In distribution | |
| 57.30.34 | In distribution | |
| 66.3703 | In distribution | |
| 70.1350 | In distribution | |
| 47-0686 | In distribution | |
| 70.1300 | In distribution | |
| 57-2833 | In distribution | |
| 57.28.33 | In distribution | |
| 47-0702 | In distribution | |
| 57.28.31 | In distribution | |
| 70.1290 | In distribution | |
| 71-2743 | In distribution | |
| 57-3034 | In distribution | |
| 71-2400 | In distribution | |
| 70.1290 | In distribution | |
| 47-0860 | In distribution | |
| 47-0860 | In distribution | |
| 70.1340 | In distribution | |
| 57.28.63 | In distribution | |
| 47-0520 | In distribution | |
| 57.28.325 | In distribution | |
| 57-2836 | In distribution | |
| 55-0991 | In distribution | |
| 55-0693 | In distribution | |
| 57.30.32 | In distribution | |
| 57.30.31 | In distribution | |
| 990.06.97 | In distribution | |
| 57-2831 | In distribution | |
| 990.06.93 | In distribution | |
| 48-0029 | In distribution | |
| 57.28.35 | In distribution | |
| 47-0732 | In distribution | |
| 57.28.32 | In distribution | |
| 57.28.33 | In distribution | |
| 47-0490 | In distribution | |
| 57-3031 | In distribution | |
| 47-0780 | In distribution | |
| 47-0685 | In distribution | |
| 57.28.34 | In distribution | |
| 57-3032 | In distribution | |
| 55-0694 | In distribution | |
| 57.30.34 | In distribution | |
| 57.28.36 | In distribution | |
| 57-2832 | In distribution | |
| 57.28.62 | In distribution | |
| 55-0691 | In distribution | |
| 990.06.95 | In distribution | |
| 66.3703 | In distribution | |
| 66.4840 | In distribution | |
| 57.28.31 | In distribution | |
| 71-2455 | In distribution | |
| 57.30.33 | In distribution | |
| 55-0926 | In distribution | |
| 57.28.35 | In distribution | |
| 57.07.79 | In distribution | |
| 47-0734 | In distribution | |
| 71-2398 | In distribution | |
| 55-0856 | In distribution | |
| 57-3033 | In distribution | |
| 66.6707 | In distribution | |
| 90-1790-03 | In distribution | |
| 57.28.34 | In distribution | |
| 68.9534 | In distribution | |
| 71.5724 | In distribution | |
| 57.30.33 | In distribution | |
| 47-0687 | In distribution | |
| 47-0302 | In distribution | |
| 990.06.94 | In distribution | |
| 71-2436 | In distribution | |
| 90-1790-02 | In distribution | |
| 57.28.325 | In distribution | |
| 7376-42 | Withdrawn | |
| 7376-43 | Withdrawn | |
| 7376-44 | Withdrawn | |
| 7376-41 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 2,994 |
| Life Instruments | Life Instrument Corp. | 1,252 |
| Novo Surgical | Novo Surgical, Inc. | 1,227 |
| Surgical Direct | Surgical Direct, Inc. | 1,208 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 712 |
| gSource | Gsource, LLC. | 509 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 397 |
| Peak MED | Peak Medical Distribution Inc | 320 |
| Aesculap | Aesculap AG | 264 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 244 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 239 |
| HNM Medical | HNM Stainless, LLC. | 186 |
Showing 12 of 438. All products under Rongeur
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.