Custom Healthcare Systems, Inc.
78 catalogue numbers from ZZ-0666, listed by Manus Medical, LLC, United States, under Kit, Surgical Instrument, Disposable. 67 manufacturers in China are registered for this product code.
67manufacturers in China registered for this device type
78catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (26), Shanghai (11), Zhejiang (9). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Winner Medical (Chongyang) Co., Ltd. | Chongyang | Hubei | Contract manufacturer | 13 |
| Wenzhou Baiyu Glasses Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 10 |
| Jiangsu Xuhe Medical Technology Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 9 |
| Nanjing HI-Tech Tape Products Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 8 |
Showing 12 of 67. All 67 manufacturers in China registered for Kit, Surgical Instrument, Disposable
Record
| Listed by | Manus Medical, LLC, United States |
|---|---|
| FDA product code | KDD |
| Device type | Kit, Surgical Instrument, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-05-14 |
| Record revised | 2023-06-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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 |
| Packaging | N/a of 25, n/a of 50, n/a of 8, pack of 25, n/a of 10, n/a of 24 |
| Distribution end date | 2023-10-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZZ-0666 | In distribution | |
| UNC-10004 | In distribution | |
| LEM011-01 | In distribution | |
| 5030 | In distribution | |
| D36-16267 | In distribution | |
| ZZ-0705 | In distribution | |
| D361525A | In distribution | |
| D36-16669 | In distribution | |
| ZZ-0958 | In distribution | |
| UNC-9510 | In distribution | |
| ZZ-0664 | In distribution | |
| B9-18847 | In distribution | |
| D362025A | In distribution | |
| D36-15960 | In distribution | |
| B9-18914 | In distribution | |
| JPK-19558 | In distribution | |
| ZZ-0694 | In distribution | |
| COMBO-17891 | In distribution | |
| D367525A | In distribution | |
| D36-18794 | In distribution | |
| ZZ-0701 | In distribution | |
| D36-16268A | In distribution | |
| ZZ-0667 | In distribution | |
| D362525A | In distribution | |
| ZZ-0703 | In distribution | |
| 12865 | In distribution | |
| UNC-10908 | In distribution | |
| D36-14623 | In distribution | |
| D36-16731 | In distribution | |
| JPK-19560 | In distribution | |
| D368525A | In distribution | |
| D360525A | In distribution | |
| D36-16662 | In distribution | |
| D36-18880 | In distribution | |
| ZZ-0665 | In distribution | |
| D8-10497 | In distribution | |
| 13324 | In distribution | |
| CHC-2155 | In distribution | |
| 14064 | In distribution | |
| B9-18815 | In distribution | |
| ZZ-0698 | In distribution | |
| B9-19630 | In distribution | |
| ZZ-0697 | In distribution | |
| SJ-19319 | In distribution | |
| ZZ-0685 | In distribution | |
| D363525A | In distribution | |
| SJ-19320 | In distribution | |
| 01-375C | In distribution | |
| D36-17014 | In distribution | |
| 12861 | In distribution | |
| B9-19168 | In distribution | |
| MWM-19224 | In distribution | |
| YMCIR-800 | In distribution | |
| A5-9171 | In distribution | |
| B9-18814 | In distribution | |
| D366525A | In distribution | |
| JPK-19757 | In distribution | |
| JPK-19605 | In distribution | |
| D36-6002BB | In distribution | |
| D364025A | In distribution | |
| 14065 | In distribution | |
| D367025A | In distribution | |
| D36-14921 | In distribution | |
| D36-5104 | In distribution | |
| D363025A | In distribution | |
| B9-18946 | In distribution | |
| B9-18825 | In distribution | |
| D368025A | In distribution | |
| SJ-19318 | In distribution | |
| ZZ-0700 | In distribution | |
| D20-10824 | In distribution | |
| D365025A | In distribution | |
| UNC-14938 | In distribution | |
| D36-16229 | In distribution | |
| D36-16269 | In distribution | |
| B9-18826 | In distribution | |
| ZZ-0702 | In distribution | |
| D8-9425B | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 789 |
| CustomEyes® | Beaver-Visitec International, Ltd | 696 |
| DeRoyal | Deroyal Industries, Inc. | 589 |
| Centurion | Centurion Medical Products Corporation | 277 |
| Readypak Kit | Beaver-Visitec International, Ltd | 196 |
| Medical Action Industries | Medical Action Industries, Inc. | 76 |
| Bioseal Inc. | Bioseal | 38 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 37 |
| In2Bones | IN2BONES USA, LLC | 24 |
| Aero-Med | Aero-MED LLC | 23 |
| Medline | Medline Industries, Inc. | 17 |
| McKesson | Mckesson Medical-Surgical Inc. | 17 |
Showing 12 of 252. All products under Kit, Surgical Instrument, Disposable
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.