Sklar®
Censitrac Ready Sklar Ring Cutter /Soft Metals
4manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Suzhou Pipi Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Foshan Maikang Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | FNS |
| Device type | Ring Cutter |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6200 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-22 |
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 | Status |
|---|---|---|
| 06-4159 | In distribution | |
| 06-4158 | In distribution | |
| 06-4152 | In distribution | |
| 06-4152C | In distribution | |
| 06-4151 | In distribution | |
| 98-425 | In distribution | |
| 06-4150 | In distribution | |
| 06-4150C | In distribution | |
| 06-4153 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BR Surgical, LLC | BR Surgical LLC | 8 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 6 |
| Beaver® | Beaver-Visitec International, Ltd | 5 |
| ADC® | American Diagnostic Corp. | 4 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 4 |
| Millennium | Avalign Technologies, Inc. | 3 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 3 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 3 |
| Gimmi | Gimmi Gmbh | 3 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 2 |
| Ring Cutter | Smith & Nephew, Inc. | 2 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 2 |
Showing 12 of 20. All products under Ring Cutter
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.