PDT, Inc.
Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R077) Younger-Good 7-8 (R226) 23 Explorer-UNC15 Probe (R245) Cone Socket Mirror Handle (R442)…
Kit Includes: (T015E-F) E-Series FlipTop™ Cassette – Fixed Rack 15 with Standard Divider (R077) Younger-Good 7-8 (R226) 23 Explorer-UNC15 Probe (R245) Cone Socket Mirror Handle (R442) Periosteal Elevator (2mm) (R443) Periosteal Elevator (3mm) (R444) End Cutting Intrasulcular Knife (R445) Modified Orban Knife (T050) #5 Mirror (15/16″) (T085) Diamond Coated Corn Suture Pliers (T087) Diamond Coated Micro Straight Pliers (17.5cm) (T088) Castroviejo Straight Tungsten Carbide Needle Holder (17.5cm) (T705) Adjustable Scalpel Handle (T815) Goldman-Fox Curved Black Scissors (12.5cm)
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 | PDT, Inc., United States |
|---|---|
| FDA product code | HXK |
| Device type | Holder, Needle; Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-01 |
| Record revised | 2025-07-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Dry Heat Sterilization |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T715 Mathieu Tungsten Carbide Needle Holder (14cm) | In distribution | |
| T088 Castroviejo Straight Tungsten Carbide Needle Holder (17.5cm) | In distribution | |
| T710 Castroviejo Straight Tungsten Carbide Needle Holder (14cm) | In distribution | |
| R926 PDT Diamond Tissue Grafting Kit | In distribution | |
| R925 PDT Bone Grafting Kit | In distribution | |
| T714 TC Needle Holder CRILE WOOD | 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 |
| Diadust | Aesculap AG | 71 |
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.