DeRoyal
Laparoscopic Gastric Bypass Pack
4manufacturers in China registered for this device type
141catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Anhui (2), Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medical Sterilizing Co., Ltd. | Hefei | Anhui | Contract manufacturer | 8 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | FDE |
| Device type | Laparoscopy Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-12 |
| Record revised | 2021-08-10 (version 3) |
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 | Case of 4, case of 6, case of 5, case of 2, case of 3, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28-0701 | In distribution | |
| 89-8281 | In distribution | |
| 89-10958 | In distribution | |
| 53-1842 | In distribution | |
| 89-7702 | In distribution | |
| 89-7231 | In distribution | |
| 89-7681 | In distribution | |
| 89-7216 | In distribution | |
| 89-6033 | In distribution | |
| 89-8766 | In distribution | |
| 89-7564 | In distribution | |
| 89-9143 | In distribution | |
| 89-9258 | In distribution | |
| 89-7370 | In distribution | |
| 89-6397 | In distribution | |
| 89-10459 | In distribution | |
| 89-3141 | In distribution | |
| 89-5978 | In distribution | |
| 90-1157 | In distribution | |
| 89-7715 | In distribution | |
| 89-9408 | In distribution | |
| 89-9362 | In distribution | |
| 89-6737 | In distribution | |
| 89-8151 | In distribution | |
| 89-8688 | In distribution | |
| 89-3940 | In distribution | |
| 89-8982 | In distribution | |
| 89-11140 | In distribution | |
| 89-7616 | In distribution | |
| 89-3605 | In distribution | |
| 89-7031 | In distribution | |
| 89-5066 | In distribution | |
| 89-3140 | In distribution | |
| 89-6309 | In distribution | |
| 89-5711 | In distribution | |
| 89-7614 | In distribution | |
| 89-9566 | In distribution | |
| 89-7714 | In distribution | |
| 89-8837 | In distribution | |
| 89-7061 | In distribution | |
| 89-9137 | In distribution | |
| 89-10704 | In distribution | |
| 89-6053 | In distribution | |
| 89-6331 | In distribution | |
| 89-7736 | In distribution | |
| 94-0267 | In distribution | |
| 89-10788 | In distribution | |
| 89-10234 | In distribution | |
| 89-6708 | In distribution | |
| 89-8536 | In distribution | |
| 89-7427 | In distribution | |
| 89-6743 | In distribution | |
| 28-0704 | In distribution | |
| 89-2690 | In distribution | |
| 89-5440 | In distribution | |
| 89-8621 | In distribution | |
| 89-8347 | In distribution | |
| 89-7537 | In distribution | |
| 89-7459 | In distribution | |
| 89-10846 | In distribution | |
| 89-7329 | In distribution | |
| 89-8519 | In distribution | |
| 89-6993 | In distribution | |
| 89-8933 | In distribution | |
| 89-6424 | In distribution | |
| 89-7063 | In distribution | |
| 89-6873 | In distribution | |
| 89-9107 | In distribution | |
| 89-9723 | In distribution | |
| 89-7330 | In distribution | |
| 89-10501 | In distribution | |
| 89-8390 | In distribution | |
| 89-7050 | In distribution | |
| 50-12067 | In distribution | |
| 89-9721 | In distribution | |
| 89-11072 | In distribution | |
| 89-0734 | In distribution | |
| 89-2991 | In distribution | |
| 89-7264 | In distribution | |
| 89-6138 | In distribution | |
| 89-9433 | In distribution | |
| 89-9355 | In distribution | |
| 89-10185 | In distribution | |
| 89-7924 | In distribution | |
| 89-5059 | In distribution | |
| WS270B | In distribution | |
| 89-11007 | In distribution | |
| 89-9037 | In distribution | |
| 89-8056 | In distribution | |
| 89-9088 | In distribution | |
| 89-9240 | In distribution | |
| 89-7041 | In distribution | |
| 89-7266 | In distribution | |
| 89-8641 | In distribution | |
| 89-9073 | In distribution | |
| 89-9482 | In distribution | |
| 89-7015 | In distribution | |
| 89-7175 | In distribution | |
| 53-1931 | In distribution | |
| 89-8071 | In distribution | |
| 89-6201 | In distribution | |
| 89-7566 | In distribution | |
| 89-7373 | In distribution | |
| 89-9078 | In distribution | |
| 89-6063 | In distribution | |
| 89-7745 | In distribution | |
| 89-7524 | In distribution | |
| 89-7344 | In distribution | |
| 89-7363 | In distribution | |
| 89-9457 | In distribution | |
| 89-7201 | In distribution | |
| 89-7974 | In distribution | |
| 28-0703 | In distribution | |
| 89-2996 | In distribution | |
| 89-5484 | In distribution | |
| 89-10834 | In distribution | |
| 89-9427 | In distribution | |
| 89-3110 | In distribution | |
| 89-10664 | In distribution | |
| 89-6967 | In distribution | |
| 89-8935 | In distribution | |
| 89-9491 | In distribution | |
| 89-7511 | In distribution | |
| 89-8355 | In distribution | |
| 89-4704 | In distribution | |
| 89-10291 | In distribution | |
| 89-4705 | In distribution | |
| 50-1388 | In distribution | |
| 89-10876 | In distribution | |
| 89-4370 | In distribution | |
| 89-8304 | In distribution | |
| 89-2582 | In distribution | |
| 89-2191 | In distribution | |
| 89-11026 | In distribution | |
| 89-5033 | In distribution | |
| 89-7419 | In distribution | |
| 89-9232 | In distribution | |
| 28-0702 | In distribution | |
| 89-9780 | In distribution | |
| 89-7417 | In distribution | |
| 89-8717 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 23,145 |
| Cardinal Health | Cardinal Health 200, LLC | 9,245 |
| ACS | American Contract Systems, Inc. | 988 |
| Aligned Medical Solutions | Aligned Medical Solutions | 156 |
| Regard™ | ROi CPS LLC | 122 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 61 |
| Medline | Medline Industries, Inc. | 19 |
| Halyard | Avid Medical, Inc. | 13 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 9 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
Showing 12 of 17. All products under Laparoscopy Kit
Recalls Naming This Product
1 recall names this product by its own identifier, 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 | 95 units |
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.