Diadust
DIADUST Micro Needle Holder, 8 1/4", (210 mm), spring type, Golfball design handle, without ratchet, diamond dust coated, titanium,aquamarine, suture up to 5/0, non-sterile, reusable
15manufacturers in China registered for this device type
71catalogue numbers in this listing
2recalls on this code
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 | Aesculap AG, Germany |
|---|---|
| FDA product code | HXK |
| Device type | Holder, Needle; Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-23 |
| Record revised | 2023-08-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FM566R | In distribution | |
| FM534R | In distribution | |
| FM536R | In distribution | |
| FM553R | In distribution | |
| FM538R | In distribution | |
| FM551R | In distribution | |
| FM525R | In distribution | |
| FM527R | In distribution | |
| FM531R | In distribution | |
| FM252T | In distribution | |
| FM521R | In distribution | |
| FM530R | In distribution | |
| FM550R | In distribution | |
| FM254T | In distribution | |
| FM218R | In distribution | |
| FM223R | In distribution | |
| BM385T | In distribution | |
| BM302R | In distribution | |
| FM564R | In distribution | |
| FM545R | In distribution | |
| FM258T | In distribution | |
| FM541R | In distribution | |
| FM240T | In distribution | |
| BM386T | In distribution | |
| FM537R | In distribution | |
| FM560R | In distribution | |
| FM238T | In distribution | |
| FM568R | In distribution | |
| FM552R | In distribution | |
| FM555R | In distribution | |
| FM548R | In distribution | |
| FM522R | In distribution | |
| FM221R | In distribution | |
| FM520R | In distribution | |
| FM276R | In distribution | |
| FM528R | In distribution | |
| BM325R | In distribution | |
| FM554R | In distribution | |
| FM539R | In distribution | |
| FM236R | In distribution | |
| FM561R | In distribution | |
| FM565R | In distribution | |
| FM543R | In distribution | |
| FM533R | In distribution | |
| FM230R | In distribution | |
| FM228R | In distribution | |
| FM542R | In distribution | |
| FM526R | In distribution | |
| FM259T | In distribution | |
| BM328R | In distribution | |
| FM233T | In distribution | |
| BM327R | In distribution | |
| FM547R | In distribution | |
| FM540R | In distribution | |
| FM567R | In distribution | |
| FM563R | In distribution | |
| FM253T | In distribution | |
| FM529R | In distribution | |
| FM546R | In distribution | |
| BM301R | In distribution | |
| FM260T | In distribution | |
| FM549R | In distribution | |
| FM234T | In distribution | |
| FM544R | In distribution | |
| FM524R | In distribution | |
| FM239T | In distribution | |
| BM387T | In distribution | |
| FM232T | In distribution | |
| FM532R | In distribution | |
| FM523R | In distribution | |
| FM535R | 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 |
| Holder, Needle; Orthopedic | Fehling Instruments GmbH | 119 |
| Marina Medical | Marina Medical Instruments, Inc. | 115 |
| Durogrip | Aesculap AG | 78 |
| Stephens Instruments | Krishna Imports Inc | 77 |
| Aesculap | Aesculap AG | 73 |
| Zoll-Dental | Zoll-Dental | 64 |
Showing 12 of 158. All products under Holder, Needle; Orthopedic
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-05-18 | Class II | Labeling Change Control | Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610. | 7 units | |
| 2019-09-25 | Class II | Labeling Change Control | Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM. | 7 pieces | 2024-04-01 |
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.