J & J Instruments
Bone Fragment FCP 6.25" Large
5manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (1), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Record
| Listed by | J & J Instruments, LLC, United States |
|---|---|
| FDA product code | EML |
| Device type | Chisel, Bone, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-11-08 |
| Record revised | 2019-01-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Sizes | Length 5.75 to 7 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 42-0610 | In distribution | |
| 42-0600 | In distribution | |
| 42-2590 | In distribution | |
| 02-020 | Length 5.75 in | In distribution |
| 42-1285 | In distribution | |
| 42-0700 | In distribution | |
| 42-0620 | In distribution | |
| 02-010 | Length 5.75 in | In distribution |
| 42-2580 | In distribution | |
| 42-1280 | In distribution | |
| 42-2585 | In distribution | |
| 42-1270 | In distribution | |
| 42-1230 | In distribution | |
| 42-0710 | In distribution | |
| 02-310 | Length 6.625 in | In distribution |
| 02-320 | Length 7 in | In distribution |
| 42-0720 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 71 |
| Quinelato | Schobell Industrial Ltda | 55 |
| Stoma® | Storz AM Mark Gmbh | 33 |
| devemed | Devemed Gmbh | 30 |
| Zoll-Dental | Zoll-Dental | 29 |
| Power Dental USA | Power Dental U.S.A. Inc. | 24 |
| Millennium | Avalign Technologies, Inc. | 16 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 16 |
| Nordent Manufacturing, Inc. | Nordent Manufacturing Inc | 15 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 14 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 14 |
| Pilling | Teleflex Medical LLC | 12 |
Showing 12 of 50. All products under Chisel, Bone, Surgical
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.