Surgical Design
Stille -Leur Rongeur, 8.5 in Double-Action - 10x18mm Bite
11manufacturers in China registered for this device type
45catalogue 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 | Surgical Design, Inc., United States |
|---|---|
| FDA product code | HTX |
| Device type | Rongeur |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2026-05-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 68 to 72 °F |
| Sizes | Length 4 to 12 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09-422 | Length 8 in | In distribution |
| ORG-153-07S | In distribution | |
| ORG-154-01SC | In distribution | |
| ORG-157S | In distribution | |
| 09-421BG | Length 8 in | In distribution |
| ORG-153-04S | In distribution | |
| ORG-153-05S | In distribution | |
| ORG-153-06S | In distribution | |
| ORG-153-08S | In distribution | |
| 11-1229 | Length 6 in | In distribution |
| 09-422BG | Length 8 in | In distribution |
| ORG-153-02S | In distribution | |
| 11-1225 | Length 5.5 in | In distribution |
| 11-1218 | Length 6 in | In distribution |
| 09-421 | Length 8 in | In distribution |
| 11-1215 | Length 5.5 in | In distribution |
| 09-731 | Length 7 in | In distribution |
| 11-1233 | Length 7 in | In distribution |
| ORG-154S | In distribution | |
| ORG-153-03S | In distribution | |
| 20-660M | In distribution | |
| 11-1271 | Length 9 in | In distribution |
| 11-1207 | Length 8 in | In distribution |
| 09-420BG | Length 8 in | In distribution |
| 09-423BG | Length 8 in | In distribution |
| 11-1317 | Length 6 in | In distribution |
| 11-1202 | Length 6.5 in | In distribution |
| 11-1230 | Length 6 in | In distribution |
| 11-1219 | Length 6 in | In distribution |
| 11-1200 | Length 6.5 in | In distribution |
| 11-1215-01 | Length 5.5 in | In distribution |
| 11-1335 | Length 10.25 in | In distribution |
| 09-745 | Length 5.5 in | In distribution |
| 11-1274 | Length 12 in | In distribution |
| 09-420 | Length 8 in | In distribution |
| 09-423 | Length 8 in | In distribution |
| 11-1319 | Length 7.5 in | In distribution |
| 11-1226 | Length 7 in | In distribution |
| ORG-154-01S | In distribution | |
| 04-620 | Length 4 in | In distribution |
| 11-1208 | Length 8 in | In distribution |
| 04-621 | In distribution | |
| 11-1318 | Length 6 in | In distribution |
| 11-1266 | Length 8.5 in | In distribution |
| ORG-153S | In distribution |
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.