Access Needle
Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy, PTC) preceding introduction of guidewires.
7manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Jiangsu Yangtze River Medical Technology Corp. | Taizhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Mermaid Medical A/S, Denmark |
|---|---|
| FDA product code | GCB |
| Device type | Needle, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-08-05 |
| Record revised | 2026-03-13 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight and keep dry |
| Packaging | Retail box of 20 |
| Sizes | Needle gauge 18 to 22 G; length 15 to 30 cm |
| Distribution end date | 2025-04-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N12118200 | Needle Gauge 18 G | Withdrawn |
| N12118150 | Needle Gauge 18 G | Withdrawn |
| N12018150 | Needle Gauge 18 G | Withdrawn |
| N10222200 | Needle Gauge 22 G | Withdrawn |
| N12018200 | Needle Gauge 18 G | Withdrawn |
| N10222300 | Needle Gauge 22 G | Withdrawn |
| N12218150 | Needle Gauge 18 G | Withdrawn |
| N12021150 | Needle Gauge 21 G | Withdrawn |
| N12021200 | Needle Gauge 21 G | Withdrawn |
| N10222250 | Needle Gauge 22 G | Withdrawn |
| N12121150 | Needle Gauge 21 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MAK-NV™ | Merit Medical Systems, Inc. | 26 |
| Cook | Cook Incorporated | 17 |
| Ring-McLean | Cook Incorporated | 16 |
| Jet-Vac Procedure Trays | PFM Medical, Inc | 16 |
| Accel® | B. Braun Medical Inc. | 12 |
| Teleflex | Teleflex Medical LLC | 8 |
| Ring | Cook Incorporated | 7 |
| M-Drain Centesis Catheter | Mermaid Medical A/S | 6 |
| Accel™ | B. Braun Interventional Systems, Inc. | 5 |
| Pilling | Teleflex Medical LLC | 4 |
| Accel Centesis Catheter | PFM Medical, Inc | 4 |
| Skater™ Introducer System | Argon Medical Devices, Inc. | 3 |
Showing 12 of 30. All products under Needle, Catheter
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.