DDP Microtome Set
Set of 18 hand-held, manual, one-piece surgical instruments intended to split/force apart bones in the face, mouth and/or jaws (e.g., palate, mandibular inferior border) during…
Set of 18 hand-held, manual, one-piece surgical instruments intended to split/force apart bones in the face, mouth and/or jaws (e.g., palate, mandibular inferior border) during maxillofacial surgery (e.g., sagittal split osteotomy procedure); they are not designed to cut or shape bone (i.e., not an osteotome). They are metal instruments with a handle and a blade at the distal working end. The Kit consists of 18 instruments, including an autoclavable surgical instrument tray.
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 | Suncoast Dental, Inc., 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 | 2022-03-10 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Microtome Kit (18) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 482 |
| 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 |
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.