DeRpyal
Laminectomy Tracecart®
24manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (11), Anhui (6), Zhejiang (4). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Changzhou Holymed Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Donghai Xingchen NON-Woven Products Co., Ltd. | North Donghai Development Zone, Lianyungang | Jiangsu | Contract manufacturer | 7 |
| Fengyang Jiehong Nonwoven Product Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 7 |
| 3A Medical Products Co., Ltd. | Liu An | Anhui | Contract manufacturer | 6 |
| Cobes Industries (Jinzhai) Co., Ltd. | Luan | Anhui | Contract manufacturer | 6 |
| Lianyungang Aiyeh Non-woven Products Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 6 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Showing 12 of 24. All 24 manufacturers in China registered for General Surgery Tray
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | LRO |
| Device type | General Surgery Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-12 |
| Record revised | 2022-06-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 53-1829 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 67,931 |
| Medline Industries, Inc. | Medline Industries, Inc. | 54,362 |
| Avid TruCustom | Avid Medical, Inc. | 13,498 |
| Halyard | Avid Medical, Inc. | 12,802 |
| ACS | American Contract Systems, Inc. | 10,337 |
| SurgiTrack | Owens & Minor Distribution, Inc. | 5,575 |
| Aligned Medical Solutions | Aligned Medical Solutions | 3,490 |
| SurgiTrackSM | Owens & Minor Distribution, Inc. | 3,364 |
| DeRoyal | Deroyal Industries, Inc. | 2,770 |
| Medline | Medline Industries, Inc. | 1,960 |
| Henry Schein | Henry Schein, Inc. | 729 |
| Stradis | Stradis Healthcare | 685 |
Showing 12 of 113. All products under General Surgery Tray
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K842648 | 1984-09-20 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 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 | 384 units | |
| 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 | 160 units | |
| 2024-02-13 | Class I | Other | DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled. | 134 tracecarts | |
| 2023-11-22 | Class II | Device Design | Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences. | 252 units | |
| 2023-09-18 | Class II | Nonconforming Material/Component | DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer t | 32 kits | |
| 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. | 4225 packs | |
| 2023-04-17 | Class II | Nonconforming Material/Component | The custom procedure packs contain light handle covers that have been recalled by another firm. | 1,391 cases (2,972 packs) | |
| 2022-12-12 | Class II | Packaging change control | DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may c | 157 packs | 2026-05-29 |
| 2022-11-28 | Class II | Nonconforming Material/Component | DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affe | 320 units | 2026-03-18 |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 57 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 560 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 60 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | ||
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 3 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 90 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 150 Kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 76 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 30 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 88 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 240 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 32 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 79 units | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 530 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 288 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 18 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 102 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 68 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 918 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 45 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 30 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 14 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 1220 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 270 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 350 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 144 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 108 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 36 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 117 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | XXX | 264 kits | |
| 2022-11-03 | Class II | Nonconforming Material/Component | DeRoyal procedure packs that contain the affected 3M Health Care Steri Drapes which have been recalled. | 156 kits |
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.