Needle
27 catalogue numbers from NDL-100-22, listed by Galt Medical Corp., United States, under Instruments, Surgical, Cardiovascular. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
27catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (1), Shandong (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 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
| Huaian Wolfram Surgical Instruments | Huaian | Jiangsu | Manufacturer | 14 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
Record
| Listed by | Galt Medical Corp., United States |
|---|---|
| FDA product code | DWS |
| Device type | Instruments, Surgical, Cardiovascular |
| Device class | Class 1 |
| Regulation | 21 CFR 870.4500 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-08-09 |
| Record revised | 2024-06-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Shelf box of 25, shipper box of 100, shipper box of 50, shelf box of 5, sipper box of 100, shipper box of 250 |
| Sizes | Needle gauge 18 to 24 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NDL-100-22 | Needle Gauge 21 G | In distribution |
| NDL-107-07 | Needle Gauge 21 G | In distribution |
| NDL-100-10 | Needle Gauge 19 G | In distribution |
| NDL-100-18 | Needle Gauge 21 G | In distribution |
| NDL-100-29 | Needle Gauge 24 G | In distribution |
| NDL-100-09 | Needle Gauge 19 G | In distribution |
| NDL-109-01 | Needle Gauge 22 G | In distribution |
| NDL-100-21 | Needle Gauge 21 G | In distribution |
| NDL-100-30 | Needle Gauge 24 G | In distribution |
| NDL-107-14 | Needle Gauge 21 G | In distribution |
| NDL-109-00 | Needle Gauge 22 G | In distribution |
| NDL-101-00 | Needle Gauge 21 G | In distribution |
| NDL-100-33 | Needle Gauge 18 G | In distribution |
| NDL-100-17 | Needle Gauge 21 G | In distribution |
| NDL-100-00 | Needle Gauge 18 G | In distribution |
| NDL-106-07 | Needle Gauge 21 G | In distribution |
| NDL-106-14 | Needle Gauge 21 G | In distribution |
| NDL-108-00 | Needle Gauge 18 G | In distribution |
| NDL-111-00 | Needle Gauge 21 G | In distribution |
| NDL-112-01 | Needle Gauge 21 G | In distribution |
| NDL-107-17 | Needle Gauge 21 G | In distribution |
| NDL-100-32 | Needle Gauge 21 G | In distribution |
| NDL-100-28 | Needle Gauge 21 G | In distribution |
| NDL-112-00 | Needle Gauge 21 G | In distribution |
| NDL-106-04 | Needle Gauge 21 G | In distribution |
| NDL-107-04 | Needle Gauge 21 G | In distribution |
| NDL-106-17 | Needle Gauge 21 G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Delacroix-Chevalier | Landanger | 1,819 |
| Landanger | Landanger | 1,213 |
| Ambler Surgical | Ambler Surgical, LLC | 1,013 |
| Pilling | Teleflex Medical LLC | 971 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 876 |
| V. Mueller | Steris Corporation | 716 |
| Novo Surgical | Novo Surgical, Inc. | 387 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 364 |
| Instruments, Surgical, Cardiovascular | Fehling Instruments GmbH | 352 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 290 |
| Avalign | Avalign Technologies, Inc. | 283 |
| Millennium | Avalign Technologies, Inc. | 272 |
Showing 12 of 472. All products under Instruments, Surgical, Cardiovascular
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Galt Medical Corp. | UDI-DI | 2025-03-27 | Class II | Process control | Due to a potential open seal in the sterile barrier packaging. | 200 needles |
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.