HU-Friedy
#1/2 Kramer-Nevins Chisel DE, Smooth HDL
5manufacturers in China registered for this device type
71catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (1), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Record
| Listed by | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | EML |
| Device type | Chisel, Bone, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-08-14 |
| Record revised | 2024-10-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2024-11-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TABANELLA3 | In distribution | |
| CSOLT3/46 | In distribution | |
| CURBAN2 | In distribution | |
| TABANELLA4 | In distribution | |
| CP3/47 | In distribution | |
| CC1 | In distribution | |
| CW1 | In distribution | |
| SPAL13KS6 | In distribution | |
| CC9 | In distribution | |
| C36/37CH | In distribution | |
| CTG-O6 | In distribution | |
| CKN75 | In distribution | |
| CO1 | In distribution | |
| PJO/3M6 | In distribution | |
| CTG | In distribution | |
| CPF4 | In distribution | |
| CB8002 | In distribution | |
| CKN55 | In distribution | |
| C36/376 | In distribution | |
| C36/377 | In distribution | |
| CBFL112 | In distribution | |
| CG2 | In distribution | |
| CC13 | In distribution | |
| CPF2/13K | In distribution | |
| CTG6 | In distribution | |
| CO26 | In distribution | |
| CW2 | In distribution | |
| CC8 | In distribution | |
| CG1 | In distribution | |
| CC2 | In distribution | |
| C36/379 | In distribution | |
| CPF36 | In distribution | |
| CP52107 | In distribution | |
| CBFL214 | In distribution | |
| PJO/2M6 | In distribution | |
| CKN1/2CH | In distribution | |
| CTG-O | In distribution | |
| CKN1/26 | In distribution | |
| SPR1/29 | In distribution | |
| CC15 | In distribution | |
| S13K/13KL6 | In distribution | |
| CTG-OCH | In distribution | |
| CM18 | In distribution | |
| CC7 | In distribution | |
| CURBAN1 | In distribution | |
| CO1CH | In distribution | |
| CPF46 | In distribution | |
| CO2CH | In distribution | |
| CPF26 | In distribution | |
| RASP | In distribution | |
| CO2 | In distribution | |
| SKRA39 | In distribution | |
| CG6 | In distribution | |
| CG5 | In distribution | |
| CKN3 | In distribution | |
| CC4 | In distribution | |
| CPF16 | In distribution | |
| CG9 | In distribution | |
| CO36 | In distribution | |
| CPKALLA | In distribution | |
| CO46 | In distribution | |
| CPF3 | Withdrawn | |
| 22-731 | Withdrawn | |
| C36/37 | Withdrawn | |
| CSOLT3/4 | Withdrawn | |
| CPF1 | Withdrawn | |
| CP56107 | Withdrawn | |
| CO3 | Withdrawn | |
| CPF2 | Withdrawn | |
| CO4 | Withdrawn | |
| CPF2MBH | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Quinelato | Schobell Industrial Ltda | 55 |
| Stoma® | Storz AM Mark Gmbh | 33 |
| devemed | Devemed Gmbh | 30 |
| Zoll-Dental | Zoll-Dental | 29 |
| Power Dental USA | Power Dental U.S.A. Inc. | 24 |
| J & J Instruments | J & J Instruments, LLC | 17 |
| Millennium | Avalign Technologies, Inc. | 16 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 16 |
| Nordent Manufacturing, Inc. | Nordent Manufacturing Inc | 15 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 14 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 14 |
| Pilling | Teleflex Medical LLC | 12 |
Showing 12 of 50. All products under Chisel, Bone, 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.