Sklar®
Censitrac Ready JR Lambotte Osteo CVD 7 Inches 12MM
4manufacturers in China registered for this device type
482catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Pengbo (Shenzhen) Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | EMM |
| Device type | Chisel, Osteotome, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-11 |
| Record revised | 2020-08-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 40-6488 | In distribution | ||
| 40-6356 | In distribution | ||
| 40-6741 | In distribution | ||
| 40-5590 | In distribution | ||
| 40-6970 | In distribution | ||
| 40-6529 | In distribution | ||
| 40-6084 | In distribution | ||
| 40-6580 | In distribution | ||
| 41-1286 | In distribution | ||
| 40-6597 | In distribution | ||
| 40-6587 | In distribution | ||
| 70-7008 | In distribution | ||
| 40-6620 | In distribution | ||
| 40-6639 | In distribution | ||
| 40-6404 | In distribution | ||
| 40-5563 | In distribution | ||
| 40-6206 | In distribution | ||
| 40-5961 | In distribution | ||
| 41-1347 | In distribution | ||
| 40-6787 | In distribution | ||
| 40-6683 | In distribution | ||
| 40-6085 | In distribution | ||
| 40-7576 | In distribution | ||
| 40-7563 | In distribution | ||
| 40-6565 | In distribution | ||
| 40-6508 | In distribution | ||
| 40-6332 | In distribution | ||
| 40-6690 | In distribution | ||
| 40-6675 | In distribution | ||
| 40-6658 | In distribution | ||
| 40-7560 | In distribution | ||
| 40-6672 | In distribution | ||
| 49-3480 | In distribution | ||
| 40-6480 | In distribution | ||
| 40-6226 | In distribution | ||
| 40-7492 | In distribution | ||
| 40-6784 | In distribution | ||
| 40-7513 | In distribution | ||
| 40-6624 | In distribution | ||
| 40-6598 | In distribution | ||
| 41-1370 | In distribution | ||
| 40-6452C | In distribution | ||
| 40-6657 | In distribution | ||
| 40-6956 | In distribution | ||
| 40-6572 | In distribution | ||
| 40-6953C | In distribution | ||
| 40-6535 | In distribution | ||
| 40-7506 | In distribution | ||
| 40-6460 | In distribution | ||
| 40-5662 | In distribution | ||
| 40-6450 | In distribution | ||
| 40-7498 | In distribution | ||
| 40-6561 | In distribution | ||
| 40-6742 | In distribution | ||
| 40-7554 | In distribution | ||
| 40-6475 | In distribution | ||
| 41-1515 | In distribution | ||
| 40-6514 | In distribution | ||
| 40-6470 | In distribution | ||
| 40-6092 | In distribution | ||
| 40-6595 | In distribution | ||
| 40-6428 | In distribution | ||
| 40-6456 | In distribution | ||
| 40-7552 | In distribution | ||
| 67-4629 | In distribution | ||
| 41-1376 | In distribution | ||
| 40-6604C | In distribution | ||
| 40-6573 | In distribution | ||
| 41-1510 | In distribution | ||
| 40-7512 | In distribution | ||
| 40-6560 | In distribution | ||
| 40-6080 | In distribution | ||
| 40-5634 | In distribution | ||
| 41-1292 | In distribution | ||
| 40-6578 | In distribution | ||
| 40-6533 | In distribution | ||
| 49-3425 | In distribution | ||
| 40-6592 | In distribution | ||
| 40-6544 | In distribution | ||
| 40-6682 | In distribution | ||
| 40-6350 | In distribution | ||
| 40-7495 | In distribution | ||
| 70-7170 | In distribution | ||
| 40-7034 | In distribution | ||
| 40-6809 | In distribution | ||
| 67-4632 | In distribution | ||
| 40-5979 | In distribution | ||
| 40-6783 | In distribution | ||
| 40-6492 | In distribution | ||
| 40-6773 | In distribution | ||
| 49-3495 | In distribution | ||
| 40-6451 | In distribution | ||
| 40-7029 | In distribution | ||
| 40-6612C | In distribution | ||
| 40-6645 | In distribution | ||
| 40-6954C | In distribution | ||
| 40-6320 | In distribution | ||
| 49-3430 | In distribution | ||
| 40-6612 | In distribution | ||
| 40-6646 | In distribution | ||
| 40-6686 | In distribution | ||
| 40-6667 | In distribution | ||
| 40-6515 | In distribution | ||
| 40-6227 | In distribution | ||
| 40-6623 | In distribution | ||
| 40-6352 | In distribution | ||
| 40-6600 | In distribution | ||
| 40-6420 | In distribution | ||
| 40-6477 | In distribution | ||
| 40-7548 | In distribution | ||
| 40-6593 | In distribution | ||
| 40-6566 | In distribution | ||
| 40-7574 | In distribution | ||
| 40-6624C | In distribution | ||
| 40-6522 | In distribution | ||
| 40-6570 | In distribution | ||
| 40-7516 | In distribution | ||
| 40-6650 | In distribution | ||
| 40-6630C | In distribution | ||
| 41-1340 | In distribution | ||
| 40-5625 | In distribution | ||
| 40-6567 | 6 | In distribution | |
| 40-7549 | In distribution | ||
| 40-7575 | In distribution | ||
| 40-6489 | In distribution | ||
| 49-3475 | In distribution | ||
| 40-6636 | In distribution | ||
| 40-6429 | In distribution | ||
| 67-4621 | In distribution | ||
| 67-4625 | In distribution | ||
| 40-6584 | In distribution | ||
| 40-6973C | In distribution | ||
| 40-6532 | In distribution | ||
| 40-6781 | In distribution | ||
| 40-6632C | In distribution | ||
| 49-3455 | In distribution | ||
| 40-7544 | In distribution | ||
| 40-7515 | In distribution | ||
| 40-6621 | In distribution | ||
| 40-6361 | In distribution | ||
| 41-1504 | In distribution | ||
| 40-6772 | In distribution | ||
| 40-7525 | In distribution | ||
| 40-6958 | In distribution | ||
| 49-3485 | In distribution | ||
| 40-5581 | In distribution | ||
| 49-3420 | In distribution | ||
| 40-7033 | In distribution | ||
| 40-6414 | In distribution | ||
| 67-4626 | In distribution | ||
| 41-1413 | In distribution | ||
| 40-6622 | In distribution | ||
| 41-1420 | In distribution | ||
| 40-6655 | In distribution | ||
| 40-6422 | In distribution | ||
| 40-5640 | In distribution | ||
| 40-6755 | In distribution | ||
| 49-3415 | In distribution | ||
| 40-7045 | In distribution | ||
| 40-6642 | In distribution | ||
| 40-6223 | In distribution | ||
| 40-7541 | In distribution | ||
| 40-6430 | In distribution | ||
| 40-6752 | In distribution | ||
| 40-7508 | In distribution | ||
| 40-5572 | In distribution | ||
| 40-6653 | In distribution | ||
| 40-6548 | In distribution | ||
| 40-7501 | In distribution | ||
| 41-1289 | In distribution | ||
| 40-6656 | In distribution | ||
| 40-6681 | In distribution | ||
| 40-6973 | In distribution | ||
| 40-6571C | In distribution | ||
| 67-4624 | In distribution | ||
| 40-6581 | In distribution | ||
| 40-7499 | In distribution | ||
| 40-7567 | 7 | In distribution | |
| 40-6224 | In distribution | ||
| 40-6357 | In distribution | ||
| 40-6684 | In distribution | ||
| 40-6455 | In distribution | ||
| 40-7038 | In distribution | ||
| 41-1345 | In distribution | ||
| 40-5977 | In distribution | ||
| 40-6524 | In distribution | ||
| 40-6354 | In distribution | ||
| 40-6782 | In distribution | ||
| 40-6806 | In distribution | ||
| 40-6373 | In distribution | ||
| 40-6549 | In distribution | ||
| 41-1284 | In distribution | ||
| 40-6674 | In distribution | ||
| 41-1355 | In distribution | ||
| 49-3450 | In distribution | ||
| 40-6331 | In distribution | ||
| 49-3405 | In distribution | ||
| 40-7526 | In distribution | ||
| 40-5975 | In distribution | ||
| 40-6431 | In distribution | ||
| 40-7500 | In distribution | ||
| 40-6591 | In distribution | ||
| 40-6603 | In distribution | ||
| 40-6955 | In distribution | ||
| 40-7036 | In distribution | ||
| 40-6607 | In distribution | ||
| 40-6220 | In distribution | ||
| 40-5642 | In distribution | ||
| 40-6262 | In distribution | ||
| 40-5960 | In distribution | ||
| 40-6263 | In distribution | ||
| 67-4634 | In distribution | ||
| 40-7497 | In distribution | ||
| 70-7009 | In distribution | ||
| 40-6583 | In distribution | ||
| 70-7003 | In distribution | ||
| 67-4622 | In distribution | ||
| 40-7527 | In distribution | ||
| 67-4623 | In distribution | ||
| 40-6586 | In distribution | ||
| 40-6785 | In distribution | ||
| 41-1295 | In distribution | ||
| 40-6218 | In distribution | ||
| 40-6562 | In distribution | ||
| 40-6980 | In distribution | ||
| 40-7531 | In distribution | ||
| 40-6212 | In distribution | ||
| 40-5610 | In distribution | ||
| 40-6333 | In distribution | ||
| 49-3470 | In distribution | ||
| 40-6563 | In distribution | ||
| 40-6371 | In distribution | ||
| 40-7035 | In distribution | ||
| 40-5566 | In distribution | ||
| 40-6324 | In distribution | ||
| 40-6552 | 9 | In distribution | |
| 40-5615 | In distribution | ||
| 40-6970C | In distribution | ||
| 40-6610C | In distribution | ||
| 40-7491 | In distribution | ||
| 40-7530 | In distribution | ||
| 49-3435 | In distribution | ||
| 49-3550 | In distribution | ||
| 40-6561C | In distribution | ||
| 40-6776 | In distribution | ||
| 40-6476 | In distribution | ||
| 40-7047 | In distribution | ||
| 40-6777 | In distribution | ||
| 40-6452 | In distribution | ||
| 67-4627 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| gSource | Gsource, LLC. | 296 |
| Tatum Surgical-Osteotome | Suncoast Dental, Inc. | 108 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 101 |
| Kohdent | Kohler Medizintechnik GmbH | 86 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 78 |
| ACE | Ace Surgical Supply Co., Inc. | 73 |
| Osteotome | KLS-Martin L.P. | 70 |
| Aesculap | Aesculap AG | 69 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 64 |
| Millennium | Avalign Technologies, Inc. | 63 |
| devemed | Devemed Gmbh | 63 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 54 |
Showing 12 of 283. All products under Chisel, Osteotome, 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.