Integra® Jarit®
Integra® Jarit® Lambotte Mini Osteotome, With POM Capped Mallet, In Canvas Roll, Set Of 8
4manufacturers in China registered for this device type
121catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Shanghai (1), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | GFI |
| Device type | Osteotome, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-02 |
| Record revised | 2023-04-25 (version 6) |
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 |
| Sizes | Width 3.5 to 22 mm; length 8 in |
| Distribution end date | 2018-10-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 250384 | In distribution | |
| 250206 | In distribution | |
| 250165 | In distribution | |
| 250322 | Width 18 mm | In distribution |
| 250200 | In distribution | |
| 250285 | In distribution | |
| 250203 | In distribution | |
| 250387 | In distribution | |
| 250386 | In distribution | |
| P3806 | In distribution | |
| 250142 | In distribution | |
| 250164 | In distribution | |
| 250392 | In distribution | |
| P4763 | Width 10 mm | In distribution |
| 250293 | In distribution | |
| 250147 | In distribution | |
| 250214 | In distribution | |
| 250260 | In distribution | |
| 250283 | In distribution | |
| 250254 | In distribution | |
| 250162 | In distribution | |
| 250058 | In distribution | |
| P3808 | In distribution | |
| 250148 | In distribution | |
| 250211 | In distribution | |
| 250149 | In distribution | |
| 250396 | In distribution | |
| 250397 | In distribution | |
| 250282 | In distribution | |
| X38600 | In distribution | |
| 250205 | In distribution | |
| 250394 | In distribution | |
| 250292 | In distribution | |
| 250056 | In distribution | |
| 250168 | In distribution | |
| 250204 | In distribution | |
| 250064 | In distribution | |
| X38712B | In distribution | |
| 250385 | In distribution | |
| P4786 | Width 12 mm | In distribution |
| 250262 | In distribution | |
| 250250 | In distribution | |
| 250053 | In distribution | |
| 250280 | In distribution | |
| 250321 | 7-3/4″ | In distribution |
| 250281 | In distribution | |
| 250215 | In distribution | |
| P1520 | Width 6.5 mm | In distribution |
| 250062 | In distribution | |
| 250253 | In distribution | |
| 250166 | In distribution | |
| P3800 | In distribution | |
| P4982 | In distribution | |
| 250286 | In distribution | |
| 250284 | In distribution | |
| 250290 | In distribution | |
| 250263 | In distribution | |
| P4885 | Length 8 in | In distribution |
| 250261 | In distribution | |
| 250146 | In distribution | |
| 250063 | In distribution | |
| 250264 | In distribution | |
| 250320 | 7-3/4″ | In distribution |
| 250202 | In distribution | |
| 250381 | In distribution | |
| 250161 | In distribution | |
| 250265 | In distribution | |
| 250054 | In distribution | |
| X38713 | In distribution | |
| 250383 | In distribution | |
| X38714 | In distribution | |
| 250395 | In distribution | |
| 250140 | In distribution | |
| 250390 | In distribution | |
| X38716 | In distribution | |
| 250391 | In distribution | |
| X38713B | In distribution | |
| 250052 | In distribution | |
| 250169 | In distribution | |
| 250210 | In distribution | |
| 250163 | In distribution | |
| P3804 | In distribution | |
| 250252 | In distribution | |
| X38385 | In distribution | |
| 250141 | In distribution | |
| P4886 | Length 8 in | In distribution |
| 250216 | In distribution | |
| 250393 | In distribution | |
| 250145 | In distribution | |
| 250201 | In distribution | |
| 250382 | In distribution | |
| P4761 | Width 3.5 mm | In distribution |
| 250160 | In distribution | |
| X38712 | In distribution | |
| 250055 | In distribution | |
| 250255 | In distribution | |
| P3802 | In distribution | |
| X38383 | In distribution | |
| 250212 | In distribution | |
| 250294 | In distribution | |
| 250167 | In distribution | |
| 250057 | In distribution | |
| 250144 | In distribution | |
| 250213 | In distribution | |
| P4762 | In distribution | |
| 250323 | 7-3/4″ | In distribution |
| 250296 | In distribution | |
| X38381 | In distribution | |
| 250295 | In distribution | |
| 250291 | In distribution | |
| P4764 | Width 14 mm | In distribution |
| 250251 | In distribution | |
| P4765 | 6-1/4″ | In distribution |
| X38711 | In distribution | |
| X38715 | In distribution | |
| 250143 | In distribution | |
| 250051 | In distribution | |
| 250061 | In distribution | |
| 250060 | In distribution | |
| 250059 | In distribution | |
| P4940 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| V. Mueller | Steris Corporation | 155 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 131 |
| Intervertebral Disc Preparation Instruments | Alphatec Spine, Inc. | 110 |
| Osteotomy Instruments | Alphatec Spine, Inc. | 109 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 97 |
| Tecomet | Tecomet, Inc. | 76 |
| Timberline Lateral Fusion System | Highridge Medical, LLC | 75 |
| Orthomed | Ortho-MED, Inc. | 73 |
| Hayden Medical | Hayden Medical Inc | 70 |
| Ambler Surgical | Ambler Surgical, LLC | 67 |
| Power Dental USA | Power Dental U.S.A. Inc. | 66 |
| Osteotome, Manual | George Tiemann & Co. | 64 |
Showing 12 of 333. All products under Osteotome, Manual
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.