DeRoyal
Cardio Institute of MI #11642 CVI Loop Pack
24manufacturers in China registered for this device type
2,770catalogue numbers in this listing
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 |
| Premarket notification | Exempt |
| Record published | 2016-09-12 |
| 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 |
| 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 3, case of 5, case of 6, case of 2, case of 8 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 89-3715 | In distribution | |
| 89-9365 | In distribution | |
| 89-5460 | In distribution | |
| 89-5481 | In distribution | |
| 89-7325 | In distribution | |
| 89-7562 | In distribution | |
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Showing 250 of 300 catalogue numbers.
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 |
| Medline | Medline Industries, Inc. | 1,960 |
| Henry Schein | Henry Schein, Inc. | 729 |
| Stradis | Stradis Healthcare | 685 |
| Centurion | Centurion Medical Products Corporation | 672 |
Showing 12 of 113. All products under General Surgery Tray
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K842648 | 1984-09-20 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| 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 | 160 units | |
| 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 | 384 units | |
| Deroyal Industries, Inc. | UDI-DI | 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 | |
| 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. | 4225 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. | 1,391 cases (2,972 packs) | |
| Deroyal Industries, Inc. | UDI-DI | 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 |
| Deroyal Industries, Inc. | UDI-DI | 2022-08-12 | Class II | Material/Component Contamination | Procedure packs contained a recalled product. | 1306 kits | 2024-09-20 |
| Deroyal Industries, Inc. | UDI-DI | 2022-03-03 | Class II | Process control | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. | 780 kits | 2022-09-15 |
| Deroyal Industries, Inc. | UDI-DI | 2022-03-03 | Class II | Process control | A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. | 1360 kits | 2022-09-15 |
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 |
|---|---|---|---|---|---|
| 2024-02-13 | 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 | |
| 2023-09-18 | 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 | |
| 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.