Integra® Jarit®
Integra® Jarit® Kolbel Retractor Set (REF#'s 225-324, 225-328, 225-329, 225-330, 225-332, 225-333, 225-334)
Who Else Makes It
Concentrated in Jiangsu (24), Guangdong (7), Zhejiang (6). 29 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
Showing 12 of 53. All 53 manufacturers in China registered for Orthopedic Manual Surgical Instrument
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | LXH |
| Device type | Orthopedic Manual Surgical Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-02 |
| Record revised | 2023-04-25 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Special storage condition: No |
| Sizes | Length 8 to 13 in; width 1.2 to 63 mm |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 225323 | In distribution | |
| 240147 | In distribution | |
| 240167 | In distribution | |
| 240232 | In distribution | |
| 225176 | In distribution | |
| 240104 | In distribution | |
| 240118 | Length 9 in | In distribution |
| 240076 | Length 8 in | In distribution |
| 225241 | In distribution | |
| 240187 | In distribution | |
| 240203 | In distribution | |
| 240085 | Length 8 in | In distribution |
| 225301 | In distribution | |
| 240175 | In distribution | |
| 240107 | In distribution | |
| 240072 | Length 8 in | In distribution |
| 225186 | In distribution | |
| 240165 | In distribution | |
| 240125 | Length 9 in | In distribution |
| 240154 | In distribution | |
| 240215 | In distribution | |
| 225135 | In distribution | |
| 240139 | In distribution | |
| 240145 | In distribution | |
| 225461 | In distribution | |
| 280552 | In distribution | |
| 240150 | In distribution | |
| 225332 | In distribution | |
| 240186 | In distribution | |
| 225408 | In distribution | |
| 225178 | In distribution | |
| 240091 | Length 8 in | In distribution |
| 240108 | In distribution | |
| 240177 | In distribution | |
| 240124 | Length 9 in | In distribution |
| 240188 | In distribution | |
| 240202 | In distribution | |
| 240171 | Length 9 in | In distribution |
| 240102 | In distribution | |
| 240120 | Length 9 in | In distribution |
| 225188 | In distribution | |
| 240182 | In distribution | |
| 240196 | In distribution | |
| 240078 | Length 8 in | In distribution |
| 270200 | In distribution | |
| 240148 | In distribution | |
| 240075 | Length 8 in | In distribution |
| 225180 | In distribution | |
| 240144 | In distribution | |
| X3892 | In distribution | |
| 240127 | Length 9 in | In distribution |
| 225327 | In distribution | |
| X38211 | In distribution | |
| 240-098 | 6-3/4″ | In distribution |
| 225328 | In distribution | |
| 225462 | In distribution | |
| 240146 | In distribution | |
| 240151 | In distribution | |
| 240214 | In distribution | |
| 240157 | In distribution | |
| 225407 | In distribution | |
| 240074 | Length 8 in | In distribution |
| 240092 | Length 8 in | In distribution |
| 270195 | In distribution | |
| 225179 | In distribution | |
| 240142 | In distribution | |
| 225115 | In distribution | |
| 240095 | Length 8 in | In distribution |
| 240208 | 4.2x10mm Cup | In distribution |
| 225121 | Length 13 in | In distribution |
| 240176 | In distribution | |
| 240172 | Length 9 in | In distribution |
| 240-099 | 6-3/4″ | In distribution |
| 225314 | In distribution | |
| 240093 | Length 8 in | In distribution |
| 240070 | Length 8 in | In distribution |
| 225324 | In distribution | |
| 240191 | In distribution | |
| 270-196 | 5-7/8″ | In distribution |
| 240197 | In distribution | |
| X3890 | In distribution | |
| 240-101 | 6-3/4″ | In distribution |
| 240160 | In distribution | |
| 240156 | In distribution | |
| 240123 | Length 9 in | In distribution |
| 240119 | Length 9 in | In distribution |
| 240192 | In distribution | |
| 240166 | In distribution | |
| 240193 | In distribution | |
| 240205 | 7-3/4″ | In distribution |
| 225311 | In distribution | |
| 240230 | In distribution | |
| 240079 | Length 8 in | In distribution |
| 225330 | In distribution | |
| 240140 | In distribution | |
| 240200 | 5-1/8″ | In distribution |
| X3807 | In distribution | |
| 240152 | In distribution | |
| 240189 | In distribution | |
| 240077 | Length 8 in | In distribution |
| 240153 | In distribution | |
| 225177 | In distribution | |
| 842620 | In distribution | |
| 240220 | In distribution | |
| 240094 | Length 8 in | In distribution |
| 240212 | In distribution | |
| 240122 | Length 9 in | In distribution |
| 240183 | In distribution | |
| 240138 | In distribution | |
| 240231 | In distribution | |
| 240105 | In distribution | |
| 240086 | Length 8 in | In distribution |
| 270187 | In distribution | |
| 225326 | In distribution | |
| 280554 | In distribution | |
| 240071 | Length 8 in | In distribution |
| 240180 | In distribution | |
| 225325 | In distribution | |
| 225497 | In distribution | |
| 240221 | In distribution | |
| 240143 | In distribution | |
| 240128 | Length 9 in | In distribution |
| 240155 | In distribution | |
| 225333 | In distribution | |
| 240089 | Length 8 in | In distribution |
| 225496 | 8-3/4″ | In distribution |
| 240179 | In distribution | |
| 240126 | Length 9 in | In distribution |
| 240185 | In distribution | |
| X3800 | In distribution | |
| 225403 | Width 13 mm | In distribution |
| 240149 | In distribution | |
| 240198 | 8-1/2″ | In distribution |
| 240073 | Length 8 in | In distribution |
| 240181 | In distribution | |
| 240159 | In distribution | |
| 240141 | In distribution | |
| 225312 | In distribution | |
| 240207 | 4.2x10mm Cup | In distribution |
| 225187 | In distribution | |
| 240216 | In distribution | |
| 240090 | Length 8 in | In distribution |
| 240088 | Length 8 in | In distribution |
| 240103 | In distribution | |
| 240087 | Length 8 in | In distribution |
| 225126 | In distribution | |
| 240162 | In distribution | |
| 240163 | In distribution | |
| 240209 | 4.2x10mm Cup | In distribution |
| 225335 | In distribution | |
| 240211 | In distribution | |
| 240195 | 3/8″ Hook | In distribution |
| 240-100 | 6-3/4″ | In distribution |
| 240158 | In distribution | |
| 225190 | In distribution | |
| 240121 | Length 9 in | In distribution |
| 240168 | In distribution | |
| 225463 | In distribution | |
| 280553 | In distribution | |
| 240161 | In distribution | |
| 240178 | In distribution | |
| 280558 | In distribution | |
| 240190 | In distribution | |
| 240164 | In distribution | |
| 225402 | 9-3/4″ | In distribution |
| 225331 | In distribution | |
| 240170 | Width 1.2 mm | In distribution |
| 225313 | In distribution | |
| 270202 | In distribution | |
| 225302 | In distribution | |
| 240080 | Length 8 in | In distribution |
| 225334 | In distribution | |
| X3809UD | 7-3/4″ | In distribution |
| 270189 | In distribution | |
| 225498 | In distribution | |
| 240210 | In distribution | |
| 270188 | In distribution | |
| 225329 | In distribution | |
| 225404 | In distribution | |
| 240106 | In distribution | |
| 225400 | 9-3/4″ | In distribution |
| 225405 | In distribution | |
| 225193 | Withdrawn | |
| 225192 | Withdrawn | |
| 225194 | Withdrawn | |
| 225191 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Razek Equipamentos | Razek Equipamentos Ltda | 11,578 |
| Orthopedic Manual Surgical Instrument | Globus Medical, Inc. | 4,784 |
| Instrument | Howmedica Osteonics Corp | 4,539 |
| Orthopedic Manual Surgical Instrument | Ortho Development Corp. | 4,076 |
| Knee Instruments | Medacta International SA | 3,944 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 3,420 |
| Arthrex® | Arthrex, Inc. | 3,106 |
| Spine Instruments | Medacta International SA | 2,892 |
| Orthopedic Manual Surgical Instrument | Medtronic Sofamor Danek, Inc. | 2,766 |
| Hip Instruments | Medacta International SA | 1,904 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 1,756 |
| ReLine | Nuvasive, Inc. | 1,208 |
Showing 12 of 9,501. All products under Orthopedic Manual Surgical Instrument
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.