Sterile Disposable Endocavity Needle Guide Kit
Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion E3-10, BK Medical 8819 & E10C4, CareStream E10C4 & E14C4, HItachi Aloka Medical UST-679, Philips BP10-5ec (Affiniti 50,…
Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion E3-10, BK Medical 8819 & E10C4, CareStream E10C4 & E14C4, HItachi Aloka Medical UST-679, Philips BP10-5ec (Affiniti 50, Affiniti 70, HD11, HD115 & HD7XE systems) & C9-4ec (HD7 XE w/3.0.1, software and above & HD9 systems), and Samsung Medison NEV4-9ES & NER4-9ES Ultrasound Transducers
Who Else Makes It
Concentrated in Jiangsu (14), Zhejiang (6), Guangdong (6). 21 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Jiangsu Likang Medical Products Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 17 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Xiantao Daoqi Plastic Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 16 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Wuhan Huaxin Nonwoven Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 13 |
| Foshan Nanhai Plus Medical Co Ltd | Foshan | Guangdong | Contract manufacturer | 12 |
| Kunshan Jiehong Nonwoven Product Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 12 |
Showing 12 of 39. All 39 manufacturers in China registered for Drape, Surgical, Antimicrobial
Record
| Listed by | Protek Medical Products, Inc., United States |
|---|---|
| FDA product code | KKX |
| Device type | Drape, Surgical, Antimicrobial |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| 510(k) | K970891 |
| Record published | 2017-10-06 |
| Record revised | 2024-02-16 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5272 | In distribution | |
| 5183 | In distribution | |
| 5252 | In distribution | |
| 5156 | In distribution | |
| 5159 | In distribution | |
| 5147 | In distribution | |
| 5533 | In distribution | |
| 5563 | In distribution | |
| 5262 | In distribution | |
| 5253 | In distribution | |
| 5263 | In distribution | |
| 5176 | In distribution | |
| 5273 | In distribution | |
| 5179 | In distribution | |
| 5071 | In distribution | |
| 5271 | In distribution | |
| 5372 | In distribution | |
| 5074 | In distribution | |
| 5148 | In distribution | |
| 5175 | In distribution | |
| 5157 | In distribution | |
| 5371 | In distribution | |
| 5072 | In distribution | |
| 5059 | In distribution | |
| 5653 | In distribution | |
| 5652 | In distribution | |
| 5562 | In distribution | |
| 5651 | In distribution | |
| 5561 | In distribution | |
| 5149 | In distribution | |
| 5151 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microtek | Microtek Medical LLC | 994 |
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 819 |
| Halyard | O&M Halyard, Inc. | 800 |
| Medline | Medline Industries, Inc. | 517 |
| Convertors | Cardinal Health 200, LLC | 392 |
| Medline Industries, Inc. | Medline Industries, Inc. | 274 |
| TIDIShield | Tidi Products, LLC | 187 |
| DeRoyal | Deroyal Industries, Inc. | 118 |
| Cardinal Health | Cardinal Health 200, LLC | 111 |
| Angiosystems Drape | Angiosystems, Inc. | 109 |
| ComPel Surgical Drape | Standard Textile Co., Inc. | 101 |
| Drape, Surgical, Antimicrobial | Welmed, Inc. | 95 |
Showing 12 of 329. All products under Drape, Surgical, Antimicrobial
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K970889 | 1997-10-20 |
| K970891 | 1997-08-22 |
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.