Digital Ivus Sterile Equipment Cover
Catalogue number 5902VC, listed by Philips Image Guided Therapy Corporation, United States, under Drape, Surgical, Antimicrobial. 39 manufacturers in China are registered for this product code.
39manufacturers in China registered for this device type
1catalogue number
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 | Philips Image Guided Therapy Corporation, United States |
|---|---|
| FDA product code | KKX |
| Device type | Drape, Surgical, Antimicrobial |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K052395 |
| Record published | 2017-03-02 |
| Record revised | 2024-08-21 (version 9) |
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 dry; Special storage condition: Keep away from sunlight |
| Packaging | Box of 100, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5902VC | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Volcano Corporation | 510(k) number | 2016-02-05 | Class II | Labeling False and Misleading | Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date. | 1355 total | 2017-03-21 |
| Volcano Corporation | 510(k) number | 2016-02-05 | Class II | Labeling False and Misleading | Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date. | 1355 total | 2017-03-21 |
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.