Unbranded
Synaptive Skirt Drape
9manufacturers in China registered for this device type
301catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Beijing (2), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Careray Digital Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Advance Medical Designs, Inc., United States |
|---|---|
| FDA product code | JAA |
| Device type | System, X-Ray, Fluoroscopic, Image-Intensified |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-29 |
| Record revised | 2024-09-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 100, pack of 20, pack of 10, pack of 25, pack of 5, pack of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09-MK650 | In distribution | |
| 07-PK808 | In distribution | |
| 71602 | In distribution | |
| CC212NS | In distribution | |
| CC400NS | In distribution | |
| SYN-0044 | In distribution | |
| 07-PK803 | In distribution | |
| 02-3654TL | In distribution | |
| 09-MK931 | In distribution | |
| 09-MK942 | In distribution | |
| 05-CD01 | In distribution | |
| 02-3648TL | In distribution | |
| F-UC31SYK | In distribution | |
| 02-3636TL | In distribution | |
| 3620-04 | In distribution | |
| 09-MK911 | In distribution | |
| 01-3628 | In distribution | |
| 07-PK807 | In distribution | |
| KP05LNS | In distribution | |
| 07-CA100 | In distribution | |
| 03-KP09 | In distribution | |
| 09-GL902 | In distribution | |
| CA108NS | In distribution | |
| 3636-04 | In distribution | |
| 01-1212 | In distribution | |
| KP18LNS | In distribution | |
| 01-2840 | In distribution | |
| 06-LK701 | In distribution | |
| 06-CLK05 | In distribution | |
| CA104NS | In distribution | |
| 09-GL901 | In distribution | |
| 09-GL903 | In distribution | |
| 04-CC224 | In distribution | |
| 06-CLK03 | In distribution | |
| 07-CA120 | In distribution | |
| 01-3636 | In distribution | |
| 01-3020 | In distribution | |
| 01-3620N | In distribution | |
| 01-3630 | In distribution | |
| 08-MK101 | In distribution | |
| 04-CC230 | In distribution | |
| CD2720NS | In distribution | |
| 07-CA201 | In distribution | |
| FS3030NS | In distribution | |
| 01-3640 | In distribution | |
| ADD-031 | In distribution | |
| 09-MK948 | In distribution | |
| 01-1020 | In distribution | |
| 04-CC212 | In distribution | |
| 71604 | In distribution | |
| 09-MK959 | In distribution | |
| CA601NS | In distribution | |
| 07-CA200 | In distribution | |
| 09-MK971 | In distribution | |
| 01-3620 | In distribution | |
| LK601NS | In distribution | |
| 09-MK952 | In distribution | |
| HK112NS | In distribution | |
| 5490C | In distribution | |
| CD03NS | In distribution | |
| 07-CA800 | In distribution | |
| 5490CNS | In distribution | |
| 09-MK950 | In distribution | |
| 09-MK941 | In distribution | |
| 07-CA400 | In distribution | |
| 07-CA114 | In distribution | |
| GL900NS | In distribution | |
| 01-2036 | In distribution | |
| 09-MK982 | In distribution | |
| 07-CA122 | In distribution | |
| KP30LNS | In distribution | |
| 09-MK937 | In distribution | |
| 09-MK945 | In distribution | |
| 01-3648 | In distribution | |
| 07-CA104 | In distribution | |
| KP22LNS | In distribution | |
| 02-2020TL | In distribution | |
| 07-PK801 | In distribution | |
| 02-5040TL | In distribution | |
| 07-PK810 | In distribution | |
| 01-5040 | In distribution | |
| 05-CD2720 | In distribution | |
| 3636-04NS | In distribution | |
| 5470CNS | In distribution | |
| 110704 | In distribution | |
| 02-2028TL | In distribution | |
| 02-3030TL | In distribution | |
| ALMCFF | In distribution | |
| 09-MK901 | In distribution | |
| 07-CA118 | In distribution | |
| 3640-04NS | In distribution | |
| 02-1212TL | In distribution | |
| 09-MK906 | In distribution | |
| 09-MK938 | In distribution | |
| CC210NS | In distribution | |
| 09-MK980 | In distribution | |
| KP26LNS | In distribution | |
| KP09LNS | In distribution | |
| 01-4425 | In distribution | |
| 09-MK908 | In distribution | |
| 03-KP26 | In distribution | |
| 09-MK960 | In distribution | |
| 09-MK947 | In distribution | |
| 01-2820 | In distribution | |
| 05-CD03 | In distribution | |
| 06-LK807 | In distribution | |
| 09-MK3957 | In distribution | |
| CC222NS | In distribution | |
| 5229056 | In distribution | |
| 07-CA105 | In distribution | |
| 09-MK652 | In distribution | |
| CC501NS | In distribution | |
| 07-CA600 | In distribution | |
| 71601 | In distribution | |
| 01-5242 | In distribution | |
| 09-MK905 | In distribution | |
| 01-5050 | In distribution | |
| 02-4020TL | In distribution | |
| SYN-0048 | In distribution | |
| 5454CNS | In distribution | |
| ALMVZ | In distribution | |
| 06-CLK04 | In distribution | |
| CD02NS | In distribution | |
| 07-PK802 | In distribution | |
| 5470C | In distribution | |
| 09-MK949 | In distribution | |
| CD01NS | In distribution | |
| 01-0512 | In distribution | |
| 09-MK970 | In distribution | |
| 09-MK974 | In distribution | |
| CA600NS | In distribution | |
| 01-2028 | In distribution | |
| 01-5030 | In distribution | |
| 09-MK961 | In distribution | |
| 3636-01 | In distribution | |
| 03-KP18 | In distribution | |
| 02-4030TL | In distribution | |
| 09-GL801 | In distribution | |
| 01-3628N | In distribution | |
| 03-KP50 | In distribution | |
| 03-KP40 | In distribution | |
| 02-4060TL | In distribution | |
| 02-0512TL | In distribution | |
| 09-MK930 | In distribution | |
| 07-CA401 | In distribution | |
| CC800NS | In distribution | |
| SYN-0043 | In distribution | |
| FS0507NS | In distribution | |
| 02-2812TL | In distribution | |
| 08-CC182 | In distribution | |
| 06-LK303 | In distribution | |
| 3644-04NS | In distribution | |
| 02-3036TL | In distribution | |
| 09-MK973 | In distribution | |
| 01-2812 | In distribution | |
| 09-GL802 | In distribution | |
| 09-GL900 | In distribution | |
| 03-KP22 | In distribution | |
| 01-5020 | In distribution | |
| 06-LK802 | In distribution | |
| 07-CA300 | In distribution | |
| 01-2040 | In distribution | |
| 06-LK803 | In distribution | |
| 01-4060 | In distribution | |
| 3620-04NS | In distribution | |
| 77900 | In distribution | |
| 06-LK801 | In distribution | |
| 01-36542R | In distribution | |
| 04-CC220 | In distribution | |
| LK901NS | In distribution | |
| 04-CC227 | In distribution | |
| 02-5050TL | In distribution | |
| 01-3030 | In distribution | |
| 09-MK932 | In distribution | |
| SYN-0019 | In distribution | |
| 02-5030TL | In distribution | |
| 04-CC222 | In distribution | |
| 09-MK653 | In distribution | |
| 5222929 | In distribution | |
| FS2020NS | In distribution | |
| 02-2840TL | In distribution | |
| 01-3654 | In distribution | |
| CC230NS | In distribution | |
| CC214NS | In distribution | |
| 02-2820TL | In distribution | |
| 09-MK903 | In distribution | |
| 09-MK935 | In distribution | |
| 02-3640TL | In distribution | |
| 04-CC400 | In distribution | |
| 09-MK933 | In distribution | |
| CA110NS | In distribution | |
| 07-CA106 | In distribution | |
| 09-GL800 | In distribution | |
| CA106NS | In distribution | |
| 02-3012TL | In distribution | |
| 09-MK968 | In distribution | |
| KP40LNS | In distribution | |
| 07-CA601 | In distribution | |
| 07-HK114 | In distribution | |
| 5454C | In distribution | |
| LK301NS | In distribution | |
| 07-CA108 | In distribution | |
| 02-3630TL | In distribution | |
| 77901 | In distribution | |
| 01-0512T | In distribution | |
| CC900NS | In distribution | |
| 01-3670 | In distribution | |
| 06-LKAV1 | In distribution | |
| 2217-04NS | In distribution | |
| 09-GL901S | In distribution | |
| 01-1010 | In distribution | |
| 3644-04 | In distribution | |
| 07-PK800 | In distribution | |
| 04-CC214 | In distribution | |
| 03-KP14 | In distribution | |
| 05-CD02 | In distribution | |
| 06-LK601 | In distribution | |
| 09-MK651 | In distribution | |
| 07-CA110 | In distribution | |
| 07-CA124 | In distribution | |
| 02-3020TL | In distribution | |
| 02-4040TL | In distribution | |
| 05-CD00 | In distribution | |
| 06-CLK01 | In distribution | |
| 09-MK3936 | In distribution | |
| 02-4430TL | In distribution | |
| 02-0512PT | In distribution | |
| 01-4030 | In distribution | |
| CA300NS | In distribution | |
| 06-LK602 | In distribution | |
| CA100NS | In distribution | |
| 09-MK921 | In distribution | |
| 03-KP05 | In distribution | |
| 02-2040TL | In distribution | |
| CC600NS | In distribution | |
| 04-CC900 | In distribution | |
| 06-LK804 | In distribution | |
| 01-3036 | In distribution | |
| 06-LK302 | In distribution | |
| 06-LK601SL | In distribution | |
| 09-MK957 | In distribution | |
| 02-3670TL | In distribution | |
| KP14LNS | In distribution | |
| 2217-04 | In distribution | |
| 01-4020 | In distribution | |
| 03-KP3680 | In distribution | |
| 01-2012 | In distribution | |
| 110702 | In distribution | |
| 09-MK953 | In distribution | |
| FS1430NS | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Preferred Medical Products, LLC | Preferred Medical Products, LLC | 324 |
| N23 CCD System | Nical SPA | 57 |
| N33 CCD System | Nical SPA | 36 |
| Trinias | Shimadzu Corp. | 31 |
| Custom Cover | Advance Medical Designs, Inc. | 15 |
| Pulse | Nuvasive, Inc. | 15 |
| Sonialvision G4 | Shimadzu Corp. | 13 |
| LessRay | Nuvasive, Inc. | 13 |
| Micro Kover | Advance Medical Designs, Inc. | 11 |
| Stephanix | Stephanix | 10 |
| Snap Kover | Advance Medical Designs, Inc. | 9 |
| System, X-Ray, Fluoroscopic, Image-Intensified | Pausch Medical GmbH | 8 |
Showing 12 of 169. All products under System, X-Ray, Fluoroscopic, Image-Intensified
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K850959 | 1985-04-09 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2004-06-18 | Not classified | Other | The product may come apart when excessive force is applied to the coupler. | 2340 units, *amended to include additional 250 units | 2004-09-03 |
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.