DeRoyal
INCISION PRO - Dressing OnlyINCISION PRO - Dressing Only
67manufacturers in China registered for this device type
589catalogue numbers in this listing
1510(k) clearance
5recalls on this code
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 | Deroyal Industries, Inc., 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-12 |
| Record revised | 2022-06-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Case of 8, case of 6, case of 10, case of 20, case of 40, case of 3 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 89-10390 | In distribution | |
| NP-6007-01 | In distribution | |
| 89-10114 | In distribution | |
| WB-140 | In distribution | |
| 89-9285 | In distribution | |
| 89-7979 | In distribution | |
| 99-0232 | In distribution | |
| 89-7471 | In distribution | |
| 89-9297 | In distribution | |
| 89-10717 | In distribution | |
| 89-10387 | In distribution | |
| 89-9921 | In distribution | |
| 47-744 | In distribution | |
| 89-5262 | In distribution | |
| 89-10478 | In distribution | |
| 89-10044 | In distribution | |
| 89-10443 | In distribution | |
| 89-7185 | In distribution | |
| NP-910 | In distribution | |
| 89-7029 | In distribution | |
| 89-5005 | In distribution | |
| 89-10309 | In distribution | |
| 89-6614CA | In distribution | |
| 89-5532 | In distribution | |
| 89-0149 | In distribution | |
| 89-10731 | In distribution | |
| 89-9475 | In distribution | |
| 25-0504K | In distribution | |
| 89-9953 | In distribution | |
| 89-9988 | In distribution | |
| 10-1257 | In distribution | |
| 30-136NS | In distribution | |
| 89-3579 | In distribution | |
| NP-6013 | In distribution | |
| 47-813K-01 | In distribution | |
| 26-004 | In distribution | |
| 89-10203 | In distribution | |
| 89-6866 | In distribution | |
| 89-9958 | In distribution | |
| 89-7240 | In distribution | |
| 32-2179 | In distribution | |
| 89-3586 | In distribution | |
| 89-10401 | In distribution | |
| 89-10122 | In distribution | |
| 89-10589 | In distribution | |
| 32-2098 | In distribution | |
| 89-9743 | In distribution | |
| NP-0060 | In distribution | |
| 89-10445 | In distribution | |
| 89-10948 | In distribution | |
| 32-403 | In distribution | |
| 89-7518 | In distribution | |
| NP-0500 | In distribution | |
| 89-9187 | In distribution | |
| 25-0403K | In distribution | |
| NP-0080LMD | In distribution | |
| 89-9282 | In distribution | |
| 50-1515 | In distribution | |
| 89-9191 | In distribution | |
| 31-279 | In distribution | |
| NP-6003 | In distribution | |
| 89-10625 | In distribution | |
| 89-8580 | In distribution | |
| 89-9881 | In distribution | |
| NP-0507 | In distribution | |
| 26-020 | In distribution | |
| 89-10344 | In distribution | |
| 89-10887 | In distribution | |
| 47-761 | In distribution | |
| WB-130 | In distribution | |
| NP-6007 | In distribution | |
| 89-6765 | In distribution | |
| 89-9371 | In distribution | |
| 89-9923 | In distribution | |
| NP-0501-EU | In distribution | |
| 89-5673 | In distribution | |
| 89-11035 | In distribution | |
| 89-9756 | In distribution | |
| 32-1598 | In distribution | |
| 89-1924 | In distribution | |
| 50-1519 | In distribution | |
| 89-9170 | In distribution | |
| 89-9586 | In distribution | |
| 89-8138 | In distribution | |
| 89-6752 | In distribution | |
| 89-10549 | In distribution | |
| 89-9219 | In distribution | |
| NP-0501 | In distribution | |
| 89-10306 | In distribution | |
| 50-10890 | In distribution | |
| 89-10199 | In distribution | |
| 89-9801 | In distribution | |
| 89-10228 | In distribution | |
| 89-9760 | In distribution | |
| 89-10197 | In distribution | |
| 89-10681 | In distribution | |
| 89-10730 | In distribution | |
| 89-7250 | In distribution | |
| WB-110 | In distribution | |
| 89-10335 | In distribution | |
| NP-0015 | In distribution | |
| 89-9141 | In distribution | |
| 89-9288 | In distribution | |
| 89-7569 | In distribution | |
| 47-813K | In distribution | |
| 89-9139 | In distribution | |
| 89-10529 | In distribution | |
| NP-6001P | In distribution | |
| 89-9284 | In distribution | |
| 25-0101K | In distribution | |
| 32-2097 | In distribution | |
| 89-10518 | In distribution | |
| 89-9492 | In distribution | |
| 79-401116 | In distribution | |
| 89-8344 | In distribution | |
| 47-614 | In distribution | |
| NP-0516 | In distribution | |
| 89-9463 | In distribution | |
| 89-9559 | In distribution | |
| 89-7502 | In distribution | |
| 89-10346 | In distribution | |
| PXAK0910 | In distribution | |
| 89-9152 | In distribution | |
| 25-0403B | In distribution | |
| 46-LB55 | In distribution | |
| 89-10029 | In distribution | |
| 89-10533 | In distribution | |
| 89-9485 | In distribution | |
| 89-10030 | In distribution | |
| 89-9125 | In distribution | |
| 89-9430 | In distribution | |
| 89-10130 | In distribution | |
| 89-9652 | In distribution | |
| 89-9307 | In distribution | |
| 89-10317 | In distribution | |
| NP-6008P | In distribution | |
| 26-001PR | In distribution | |
| NP-7DAYKIT | In distribution | |
| NP-21DAYKIT | In distribution | |
| 89-9279 | In distribution | |
| 89-2691 | In distribution | |
| 32-1866 | In distribution | |
| 53-1971 | In distribution | |
| 89-9560 | In distribution | |
| 89-10015 | In distribution | |
| ACC-019 | In distribution | |
| 89-10559 | In distribution | |
| 89-9315 | In distribution | |
| 50-11068NG | In distribution | |
| 89-9338 | In distribution | |
| 89-9952 | In distribution | |
| 89-10584 | In distribution | |
| 89-9093 | In distribution | |
| 89-7364 | In distribution | |
| 89-10613 | In distribution | |
| 77-400566 | In distribution | |
| 89-9925 | In distribution | |
| 89-10075 | In distribution | |
| 89-10341 | In distribution | |
| 89-5326 | In distribution | |
| 89-10523 | In distribution | |
| PXAK1022 | In distribution | |
| 89-7203 | In distribution | |
| NSMNP-6006 | In distribution | |
| 89-10182 | In distribution | |
| 89-9228 | In distribution | |
| 89-10345 | In distribution | |
| 89-10084 | In distribution | |
| 89-9791 | In distribution | |
| 89-7554 | In distribution | |
| WB-100 | In distribution | |
| 89-10729 | In distribution | |
| 89-9019 | In distribution | |
| 89-10031 | In distribution | |
| 89-5006 | In distribution | |
| 89-9497 | In distribution | |
| 89-7025 | In distribution | |
| 89-9429 | In distribution | |
| 89-1434 | In distribution | |
| NP-0014 | In distribution | |
| 50-10751 | In distribution | |
| 89-10080 | In distribution | |
| 89-7068 | In distribution | |
| NP-6008-01 | In distribution | |
| 89-9011 | In distribution | |
| 89-7575 | In distribution | |
| 89-10463 | In distribution | |
| 89-6979 | In distribution | |
| WB-150 | In distribution | |
| 89-11068 | In distribution | |
| 32-702 | In distribution | |
| 89-10646 | In distribution | |
| 89-9072 | In distribution | |
| 89-9563 | In distribution | |
| 89-9464 | In distribution | |
| 89-2697 | In distribution | |
| 89-11262 | In distribution | |
| 89-9252 | In distribution | |
| 89-9182 | In distribution | |
| 89-7269 | In distribution | |
| 89-7448 | In distribution | |
| 89-10550 | In distribution | |
| 89-9994 | In distribution | |
| 30-136 | In distribution | |
| 89-10321 | In distribution | |
| 89-9257 | In distribution | |
| 26-002NS | In distribution | |
| 89-9458 | In distribution | |
| 89-10627 | In distribution | |
| 89-6899 | In distribution | |
| 50-1517 | In distribution | |
| 89-10087 | In distribution | |
| 89-10318 | In distribution | |
| 89-10641 | In distribution | |
| WB-120 | In distribution | |
| NP-6014 | In distribution | |
| 89-9122 | In distribution | |
| NP-6008 | In distribution | |
| 89-10781 | In distribution | |
| 89-9645 | In distribution | |
| 89-8807 | In distribution | |
| 89-10601 | In distribution | |
| NP-0080 | In distribution | |
| 89-10034 | In distribution | |
| 32-1994 | In distribution | |
| 89-9135 | In distribution | |
| 89-10071 | In distribution | |
| RSK-MED | In distribution | |
| 89-10101 | In distribution | |
| 89-7254 | In distribution | |
| 77-401074 | In distribution | |
| 89-10377 | In distribution | |
| NP-7DAYKITHH | In distribution | |
| 89-10619 | In distribution | |
| 89-3243 | In distribution | |
| 50-5610 | In distribution | |
| NSMNP-6008 | In distribution | |
| 26-001NS | In distribution | |
| 32-2100 | In distribution | |
| 89-9214 | In distribution | |
| 89-10338 | In distribution | |
| 89-9331 | In distribution | |
| NP-6001 | In distribution | |
| 89-10210 | In distribution | |
| NP-0503 | In distribution | |
| 89-10019 | In distribution | |
| 89-5743 | In distribution | |
| 89-7356 | In distribution | |
| NP-0506 | In distribution | |
| 89-8177 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 789 |
| CustomEyes® | Beaver-Visitec International, Ltd | 696 |
| Centurion | Centurion Medical Products Corporation | 277 |
| Readypak Kit | Beaver-Visitec International, Ltd | 196 |
| Custom Healthcare Systems, Inc. | Manus Medical, LLC | 78 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K842627 | 1984-09-26 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | UDI-DI | 2024-10-03 | Class II | Under Investigation by firm | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged int | 780 units |
| Deroyal Industries, Inc. | UDI-DI | 2023-05-30 | Class II | Process control | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 328 packs |
| Deroyal Industries, Inc. | UDI-DI | 2023-04-17 | Class II | Nonconforming Material/Component | The custom procedure packs contain light handle covers that have been recalled by another firm. | 23 cases (52 packs) |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-04-24 | Class II | Other | DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging. | 352 trays with 7923 syringes | 2022-05-26 |
| 2008-10-01 | Not classified | Nonconforming Material/Component | Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges. | 30 kits | 2009-12-02 |
| 2008-10-01 | Not classified | Nonconforming Material/Component | Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges. | 4 kits | 2009-12-02 |
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.