IM Nail Dispenser Mold
4 catalogue numbers from 01-IMABC13-R, listed by Bonesetter Holdings, LLC, United States, under Injector, Vertebroplasty (Does Not Contain Cement). 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Beijing (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Changmei Medtech Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Shanghai Lange Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 16 |
| Ningbo Hicren Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Bonesetter Holdings, LLC, United States |
|---|---|
| FDA product code | OAR |
| Device type | Injector, Vertebroplasty (Does Not Contain Cement) |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4200 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-01-10 |
| Record revised | 2024-01-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 4 |
| Sizes | Lumen/inner diameter 11 to 13 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01-IMABC13-R | Lumen/Inner Diameter 11 mm | In distribution |
| 01-IMABC11-R | Lumen/Inner Diameter 11 mm | In distribution |
| 01-IMABC13-A | Lumen/Inner Diameter 13 mm | In distribution |
| 01-IMABC11-A | Lumen/Inner Diameter 11 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biopsybell | Biopsybell SRL | 18 |
| Medinaut-V | Imedicom Co., Ltd. | 16 |
| Injector, Vertebroplasty (Does Not Contain Cement) | Stryker GmbH | 14 |
| KMC Bone Cement Delivery System | Shanghai KiNETIC Medical Co Ltd | 9 |
| K2M Fenestrated Tap System | VB Spine LLC | 7 |
| iVAS | Stryker GmbH | 7 |
| VertePort X4 Manifold | Stryker GmbH | 6 |
| Aliquot | Stryker GmbH | 5 |
| Dfine® | Merit Medical Systems, Inc. | 5 |
| Synject | Synthes Gmbh | 4 |
| VertePort | Stryker GmbH | 4 |
| PCD | Stryker GmbH | 3 |
Showing 12 of 50. All products under Injector, Vertebroplasty (Does Not Contain Cement)
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.