Surgical Direct
MicroFrance Pediatric Backbiter, Curved Down Overall Length 105mm Working Length 80mm 1.5mm x 3.0mm Bite Working Length 80mm 1.5mm x 3.0mm Bite
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 Direct, 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 | 2022-12-01 |
| Record revised | 2025-05-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2025-05-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD92381415 | In distribution | |
| SDI06004D | In distribution | |
| SD921202136 | In distribution | |
| SD922766070 | In distribution | |
| SD92274310 | In distribution | |
| SD91481110 | In distribution | |
| S22745.100 | In distribution | |
| SD92380216 | In distribution | |
| SD48-6133 | In distribution | |
| SD922715112 | In distribution | |
| SD922813203 | In distribution | |
| SDG12519 | In distribution | |
| SD922809104 | In distribution | |
| SD77510-15 | In distribution | |
| SD91804025 | In distribution | |
| SD922745100 | In distribution | |
| SD922770000 | In distribution | |
| SD922713004 | In distribution | |
| SD921203120 | In distribution | |
| SD42959 | In distribution | |
| SD92118032 | In distribution | |
| SD91486410 | In distribution | |
| SD92274309 | In distribution | |
| SDG10806 | In distribution | |
| SD922805176 | In distribution | |
| SD91480012 | In distribution | |
| SD922733030 | In distribution | |
| SD92272502 | In distribution | |
| SDI06002 | In distribution | |
| SD92274400 | In distribution | |
| SD91487019 | In distribution | |
| SD22745-06 | In distribution | |
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| SD923809100 | In distribution | |
| SD922766040 | In distribution | |
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| SD62-6545 | In distribution | |
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| SD48-2000LH | In distribution | |
| SD921202100 | In distribution | |
| SD482046-128 | In distribution | |
| SDG10407 | In distribution | |
| SD91488510 | In distribution | |
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| SD48-3905RH | In distribution | |
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| SD50-4713 | In distribution | |
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| SD480900-128 | In distribution | |
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| SD921187131 | In distribution | |
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| SD922744101 | In distribution | |
| SD91434015 | In distribution | |
| S22742.100 | In distribution | |
| SD92117001 | In distribution | |
| SD33-5MM40 | In distribution | |
| SD485633-188 | In distribution | |
| SD92276401 | In distribution | |
| SD92278102 | In distribution | |
| SD922747102 | In distribution | |
| SD921206100 | In distribution | |
| SD22745-1016 | In distribution | |
| SD92271305 | In distribution | |
| SD922776101 | In distribution | |
| SD48-2051 | In distribution | |
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| SDG12419 | In distribution | |
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| SD14505-1000 | In distribution | |
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| SD92118502 | In distribution | |
| SD91480014 | In distribution | |
| SD923821102 | In distribution | |
| SD66453-01 | In distribution | |
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| SD67-60370UC | In distribution | |
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| SD2280-8300 | In distribution | |
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| SDI13504D | In distribution | |
| SD91432013 | In distribution | |
| SD92272002 | In distribution | |
| SD48-0097 | In distribution | |
| SD50-4814CC | In distribution | |
| SD921176101 | In distribution | |
| SD1-011020 | In distribution | |
| SD91485222 | In distribution | |
| SD921286125 | In distribution | |
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| SD921286134 | In distribution | |
| SD92273303 | In distribution | |
| SD22745-08 | In distribution | |
| SD48-10201 | In distribution | |
| SD92117003 | In distribution | |
| SDI06002R | In distribution | |
| SD922702101 | In distribution | |
| SD922767103 | In distribution | |
| SD48-0156LH | In distribution | |
| SD922805119 | In distribution | |
| SD92118510 | In distribution | |
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| SD92274734 | In distribution | |
| SD922805165 | In distribution | |
| SD914815100 | In distribution | |
| SD22745-1000 | In distribution | |
| SD922805138 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 180 |
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.