Holder, Needle; Orthopedic
CERAMO ROCERAMO PLANO-S micro needle holder, bayo. str. 0.4 x 200mm
15manufacturers in China registered for this device type
119catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (3), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medpurest Medical Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 46 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Ningbo Yingmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 29 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
Showing 12 of 15. All 15 manufacturers in China registered for Holder, Needle; Orthopedic
Record
| Listed by | Fehling Instruments GmbH, Germany |
|---|---|
| FDA product code | HXK |
| Device type | Holder, Needle; Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-01-11 |
| Record revised | 2026-07-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KOA-1 | In distribution | |
| KOT-4 | In distribution | |
| KAS-2 | In distribution | |
| KOA-5S | In distribution | |
| KOM-4 | In distribution | |
| KOV-9 | In distribution | |
| KOA-4S | In distribution | |
| KOT-7S | In distribution | |
| KOT-8S | In distribution | |
| TOS-0 | In distribution | |
| KOA-0 | In distribution | |
| MRT-6 | In distribution | |
| KOA-8 | In distribution | |
| KAP-5 | In distribution | |
| KOD-1 | In distribution | |
| KOB-6 | In distribution | |
| KOB-5 | In distribution | |
| MQY-1G | In distribution | |
| KOZ-4 | In distribution | |
| KOU-8S | In distribution | |
| KOT-3 | In distribution | |
| KOD-2 | In distribution | |
| KAP-8 | In distribution | |
| KOG-6 | In distribution | |
| KOD-6 | In distribution | |
| KOU-9 | In distribution | |
| KOL-7 | In distribution | |
| KOA-1S | In distribution | |
| KOY-7 | In distribution | |
| KOD-3 | In distribution | |
| KOB-3 | In distribution | |
| MSO-1 | In distribution | |
| KOW-0 | In distribution | |
| KOC-5 | In distribution | |
| KOT-5S | In distribution | |
| KOU-3 | In distribution | |
| KAG-9 | In distribution | |
| KAH-2 | In distribution | |
| KOM-5 | In distribution | |
| KOL-5S | In distribution | |
| MSO-1L | In distribution | |
| MRB-1 | In distribution | |
| KOV-2 | In distribution | |
| KOT-6 | In distribution | |
| TOQ-2 | In distribution | |
| KAS-4 | In distribution | |
| MSO-5 | In distribution | |
| KOU-4 | In distribution | |
| KOA-8S | In distribution | |
| KOD-5 | In distribution | |
| MRG-8 | In distribution | |
| KOS-9 | In distribution | |
| KOE-2S | In distribution | |
| KOA-9 | In distribution | |
| KOA-7S | In distribution | |
| KOA-6S | In distribution | |
| KOD-9S | In distribution | |
| KBW-2 | In distribution | |
| MRB-3 | In distribution | |
| KOM-3 | In distribution | |
| KOU-5 | In distribution | |
| KOZ-2 | In distribution | |
| MRB-2 | In distribution | |
| KOD-9 | In distribution | |
| MRC-4 | In distribution | |
| KOU-7 | In distribution | |
| KOA-3S | In distribution | |
| KOA-0S | In distribution | |
| KOE-2 | In distribution | |
| MSP-6 | In distribution | |
| MRB-1L | In distribution | |
| MRC-4L | In distribution | |
| KOU-0 | In distribution | |
| KOD-7 | In distribution | |
| KOU-6 | In distribution | |
| KOL-5 | In distribution | |
| MRG-9L | In distribution | |
| KOD-3S | In distribution | |
| KOL-8 | In distribution | |
| KOU-9S | In distribution | |
| MRG-2 | In distribution | |
| KOC-4 | In distribution | |
| KOA-5 | In distribution | |
| KAP-7 | In distribution | |
| KAH-3 | In distribution | |
| KOT-7 | In distribution | |
| KAS-3 | In distribution | |
| KOM-9 | In distribution | |
| KOM-7 | In distribution | |
| MRG-9 | In distribution | |
| KOC-3 | In distribution | |
| KOL-3S | In distribution | |
| KOB-7 | In distribution | |
| KAH-4 | In distribution | |
| KOE-9 | In distribution | |
| KOT-6S | In distribution | |
| KOU-8 | In distribution | |
| KOF-1 | In distribution | |
| KOY-2 | In distribution | |
| MRC-5 | In distribution | |
| KOE-0 | In distribution | |
| KAR-1 | In distribution | |
| KOA-6 | In distribution | |
| MRD-5 | In distribution | |
| KOE-9S | In distribution | |
| TOQ-1 | In distribution | |
| KOD-4S | In distribution | |
| KOK-7 | In distribution | |
| KAP-6 | In distribution | |
| KOA-7 | In distribution | |
| MQX-4G | In distribution | |
| KOL-7S | In distribution | |
| KOT-5 | In distribution | |
| KOA-3 | In distribution | |
| KAH-1 | In distribution | |
| KOT-8 | In distribution | |
| KOZ-3 | In distribution | |
| KOT-3S | In distribution | |
| KOC-7 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 675 |
| Needle Holder | KLS-Martin L.P. | 183 |
| Anmuth Medical International | Anmuth Medical International LLC | 148 |
| gSource | Gsource, LLC. | 147 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 139 |
| Orthomed | Ortho-MED, Inc. | 134 |
| Marina Medical | Marina Medical Instruments, Inc. | 115 |
| Durogrip | Aesculap AG | 78 |
| Stephens Instruments | Krishna Imports Inc | 77 |
| Aesculap | Aesculap AG | 73 |
| Diadust | Aesculap AG | 71 |
| Zoll-Dental | Zoll-Dental | 64 |
Showing 12 of 158. All products under Holder, Needle; Orthopedic
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.