Manus Medical, LLC
Silicone Tubing, ID 3/16" X OD 5/16" (40")
24manufacturers in China registered for this device type
11catalogue numbers in this listing
30recalls 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 | Manus Medical, LLC, 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, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 50, pack of 8, pack of 24, pack of 20, pack of 30, pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KM5072-1 | In distribution | |
| COMBO-17891-1 | In distribution | |
| MWM-20711 | In distribution | |
| M400-20648 | In distribution | |
| 14825-1 | In distribution | |
| BTPS FLUSH 01-1 | In distribution | |
| B9-18847-1 | In distribution | |
| 14062-1 | In distribution | |
| MWM-18364-F8 | In distribution | |
| MANUS20674 | In distribution | |
| R1166-1 | 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
Recalls
30 of these are 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 |
|---|---|---|---|---|---|
| 2019-12-20 | Class II | Labeling False and Misleading | A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience Kit contained LATEX. | 240 kits | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 150 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 100 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 50 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 200 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 48 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 72 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 150 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 300 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 40 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 4500 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 89 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 630 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | (1) 750 units (2) 200 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 80 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 1250 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 150 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 150 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 30 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 160 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | (1) 180 units (2)180 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 50 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 72832 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 7200 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 50 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 250 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 60 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 100 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 48 units | 2022-08-01 |
| 2018-08-13 | Class II | Packaging | Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility | 24 units | 2022-08-01 |
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.