DeRoyal
Laparoscopic GYN Robotictracecart®
1manufacturer
42catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | OHD |
| Device type | Gynecological Laparoscopic Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| 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 4) |
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 6, case of 5, case of 3, case of 4, case of 2, case of 8 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 89-2176 | In distribution | |
| 89-8758 | In distribution | |
| 89-10057 | In distribution | |
| 89-8972 | In distribution | |
| 89-9207 | In distribution | |
| 89-10880 | In distribution | |
| 89-7051 | In distribution | |
| 89-7545 | In distribution | |
| 89-10667 | In distribution | |
| 89-2995 | In distribution | |
| 53-1972 | In distribution | |
| 89-9356 | In distribution | |
| 89-8731 | In distribution | |
| 89-9364 | In distribution | |
| 89-9411 | In distribution | |
| 89-8284 | In distribution | |
| 89-2688 | In distribution | |
| 89-2528 | In distribution | |
| 53-1843 | In distribution | |
| 89-9506 | In distribution | |
| 89-7667 | In distribution | |
| 89-10231 | In distribution | |
| 89-8532 | In distribution | |
| 89-10470 | In distribution | |
| 89-7500 | In distribution | |
| 89-10520 | In distribution | |
| 89-9409 | In distribution | |
| 89-5034 | In distribution | |
| 89-7075 | In distribution | |
| 53-1958 | In distribution | |
| 89-8854 | In distribution | |
| 50-11768 | In distribution | |
| 53-1944 | In distribution | |
| 89-7410 | In distribution | |
| 89-9172 | In distribution | |
| 89-9256 | In distribution | |
| 89-8070 | In distribution | |
| 89-7217 | In distribution | |
| 89-10712 | In distribution | |
| 89-9435 | In distribution | |
| 89-8945 | In distribution | |
| 89-8348 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 16,238 |
| Medline Industries, Inc. | Medline Industries, Inc. | 6,429 |
| ACS | American Contract Systems, Inc. | 739 |
| Aligned Medical Solutions | Aligned Medical Solutions | 112 |
| Regard™ | ROi CPS LLC | 71 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 26 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 15 |
| BR Surgical, LLC | BR Surgical LLC | 15 |
| Medical Action Industries | Medical Action Industries, Inc. | 13 |
| Medline | Medline Industries, Inc. | 11 |
| Halyard | Avid Medical, Inc. | 7 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 4 |
Showing 12 of 14. All products under Gynecological Laparoscopic Kit
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.