ACE Medical
PVD SARA Coated Black Rotating Kerrison 8" 2mm Slight Curve Thin Footplate For Use with ACEROT-H
1manufacturer
64catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. 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 |
Record
| Listed by | Ebner Medical LLC, United States |
|---|---|
| FDA product code | HAE |
| Device type | Rongeur, Manual |
| Device class | Class 2 |
| Regulation | 21 CFR 882.4840 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K200387 |
| Record published | 2021-06-08 |
| Record revised | 2025-04-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| Sizes | Width 1 to 6 mm; length 5 to 10 in; length 20 cm; width 2 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ACE07-30S EX | Length 7 in | In distribution |
| ACE08-60S EX | Length 8 in | In distribution |
| ACE10-50T EX | Length 10 in | In distribution |
| ACE08-30F EX | Length 8 in | In distribution |
| ACE07-40F EX | Length 7 in | In distribution |
| ACE08-20F EX | Length 8 in | In distribution |
| ACE08-10S EX | Width 1 mm | In distribution |
| ACE08-35T EX | Length 8 in | In distribution |
| ACEBAY06-10T | Length 6 in | In distribution |
| ACE08-50S EX | Length 8 in | In distribution |
| ACE08-10T EX | Length 8 in | In distribution |
| ACE10-20T EX | Length 10 in | In distribution |
| ACE08-40S EX | Length 8 in | In distribution |
| ACE07-60T EX | Length 7 in | In distribution |
| ACE10-60S EX | Length 10 in | In distribution |
| ACEROT-H | In distribution | |
| ACE08-40T EX | Length 8 in | In distribution |
| ACEROT-40T | Length 20 cm | In distribution |
| ACE07-20S EX | Length 7 in | In distribution |
| ACE08-10F EX | Length 8 in | In distribution |
| ACEROT-30T | Length 20 cm | In distribution |
| ACEFOR08-20 EX | Length 8 in | In distribution |
| ACE08-40F EX | Length 8 in | In distribution |
| ACEROT-20T | Length 20 cm | In distribution |
| ACE10-10T EX | Length 10 in | In distribution |
| ACE10-20S EX | Length 10 in | In distribution |
| ACE10-10S EX | Length 10 in | In distribution |
| ACE08-15T EX | Length 8 in | In distribution |
| ACEBAY06-20T | Length 6 in | In distribution |
| ACE10-30S EX | Length 10 in | In distribution |
| ACESL10-30S | Length 10 in | In distribution |
| ACESL08-20S | Length 8 in | In distribution |
| ACE08-20T EX | Length 8 in | In distribution |
| ACE07-10S EX | Length 7 in | In distribution |
| ACE07-25T EX | Length 7 in | In distribution |
| ACE10-40T EX | Width 4 mm | In distribution |
| ACE07-50T EX | Length 7 in | In distribution |
| ACESL10-20S | Length 10 in | In distribution |
| ACE07-40T EX | Length 7 in | In distribution |
| ACE08-20S EX | Length 8 in | In distribution |
| ACE08-30S EX | Length 8 in | In distribution |
| ACE08-50T EX | Length 8 in | In distribution |
| ACE10-40S EX | Length 10 in | In distribution |
| ACE07-20F EX | Length 7 in | In distribution |
| ACEBAY05-50T | Length 5 in | In distribution |
| ACE07-30T EX | Length 7 in | In distribution |
| ACEBAY05-40T | Length 5 in | In distribution |
| ACEROT-20TC | Length 20 cm | In distribution |
| ACESL08-30S | Length 8 in | In distribution |
| ACE08-25T EX | Length 8 in | In distribution |
| ACEROT-30TC | Length 20 cm | In distribution |
| ACE08-60T EX | Length 8 in | In distribution |
| ACE07-40S EX | Length 7 in | In distribution |
| AA9781230 | Length 20.0 cm | In distribution |
| ACE07-10T EX | Length 7 in | In distribution |
| ACE07-30F EX | Length 7 in | In distribution |
| ACE10-30T EX | Length 10 in | In distribution |
| ACE07-10F EX | Length 7 in | In distribution |
| ACEFOR08-30 EX | Length 8 in | In distribution |
| ACE07-15S EX | Length 7 in | In distribution |
| ACE07-20T EX | Length 7 in | In distribution |
| ACE07-15T EX | Length 7 in | In distribution |
| ACE10-50S EX | Length 10 in | In distribution |
| ACE08-30T EX | Length 8 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 1,397 |
| GEN2 | Surgix Medical LLC | 1,350 |
| Boss Instruments | Boss Instruments, Ltd. | 1,086 |
| Avalign | Avalign Technologies, Inc. | 881 |
| Ambler Surgical | Ambler Surgical, LLC | 723 |
| V. Mueller | Steris Corporation | 685 |
| Integra® Ruggles®-Redmond™ | Integra LifeSciences Production Corporation | 476 |
| Rongeur, Manual | Fehling Instruments GmbH | 383 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 365 |
| Wiggins Medical | Ebner Medical LLC | 343 |
| Punch | KLS-Martin L.P. | 333 |
| Stealth Surgical | Boss Instruments, Ltd. | 242 |
Showing 12 of 158. All products under Rongeur, Manual
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.