Custom Healthcare Systems Inc.
222 catalogue numbers from MP-005, listed by Manus Medical, LLC, United States, under General Surgery Tray. 24 manufacturers in China are registered for this product code.
24manufacturers in China registered for this device type
222catalogue 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 | 2018-07-25 |
| Record revised | 2023-06-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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, serial number |
| Packaging | N/a of 20, n/a of 10, n/a of 16, n/a of 8, na of 5, n/a of 6 |
| Distribution end date | 2023-11-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MP-005 | In distribution | |
| B9-15934C | In distribution | |
| D14-3000 | In distribution | |
| 2750BNRL | In distribution | |
| L1000 | In distribution | |
| ZZ-0684 | In distribution | |
| B9-17972 | In distribution | |
| PCK-18013A | In distribution | |
| B8-17070 | In distribution | |
| UNC-19544 | In distribution | |
| S17347B | In distribution | |
| UNC-9790 | In distribution | |
| KM3403356 | In distribution | |
| B9-17401 | In distribution | |
| CUS1367-02 | In distribution | |
| B9-9754 | In distribution | |
| B9-16951-2 | In distribution | |
| MP-002 | In distribution | |
| L1000-19809 | In distribution | |
| B9-15321 | In distribution | |
| B9-18339B | In distribution | |
| KM3405251 | In distribution | |
| B9-18272 | In distribution | |
| NINE001 | In distribution | |
| UNC-9520 | In distribution | |
| DF01EKB | In distribution | |
| B9-19784 | In distribution | |
| 6873011 | In distribution | |
| NINE005 | In distribution | |
| UNC-11384 | In distribution | |
| CHM-10973 | In distribution | |
| B9-15635 | In distribution | |
| M200-19808 | In distribution | |
| B9-15632 | In distribution | |
| BRSC-15857B | In distribution | |
| MM-13713 | In distribution | |
| RAC-320 | In distribution | |
| UNC-10956 | In distribution | |
| M300 | In distribution | |
| M100-19565 | In distribution | |
| S1528-02 | In distribution | |
| UNC-18917 | In distribution | |
| 4873011 | In distribution | |
| S2744-03 | In distribution | |
| 94-59041-C | In distribution | |
| 14855A | In distribution | |
| B9-15263A | In distribution | |
| MDCS-19006 | In distribution | |
| POK-17822 | In distribution | |
| MCCS01 | In distribution | |
| D36-8931 | In distribution | |
| B9-15323A | In distribution | |
| KM5072 | In distribution | |
| KER-53630 | In distribution | |
| KM3405432 | In distribution | |
| 83-0011 | In distribution | |
| B9-17799D | In distribution | |
| SK-11489 | In distribution | |
| UNC-9481B | In distribution | |
| 13728 | In distribution | |
| B9-16350C | In distribution | |
| SJ-19441 | In distribution | |
| NINE008 | In distribution | |
| D36-11219A | In distribution | |
| B9-15322 | In distribution | |
| NINE009 | In distribution | |
| A3-15793 | In distribution | |
| B9-19785 | In distribution | |
| B9-15692A | In distribution | |
| CJD-16914 | In distribution | |
| L2000-19173 | In distribution | |
| B9-16261 | In distribution | |
| B9-16951-3 | In distribution | |
| L1000-19338 | In distribution | |
| 825X-2 | In distribution | |
| YM-18918 | In distribution | |
| UNC-18963 | In distribution | |
| R1544 | In distribution | |
| R401 | In distribution | |
| L3000 | In distribution | |
| A3-7954 | In distribution | |
| POK-17822B | In distribution | |
| UNC-10721 | In distribution | |
| 20AB0104 | In distribution | |
| B9-17066 | In distribution | |
| S1528H | In distribution | |
| 83-0016 | In distribution | |
| UNC-14771 | In distribution | |
| DT-19714 | In distribution | |
| 5026CL-13 | In distribution | |
| PAK-19244 | In distribution | |
| 14934B | In distribution | |
| FST-0001 | In distribution | |
| RAC-100 | In distribution | |
| B8-10460 | In distribution | |
| T&A-15968 | In distribution | |
| S5000-A | In distribution | |
| B9-15634B | In distribution | |
| B9-19530 | In distribution | |
| B8-9842 | In distribution | |
| B446MM-D | In distribution | |
| KIT4-873011 | In distribution | |
| B9-19703 | In distribution | |
| B9-16938 | In distribution | |
| UNC-10916 | In distribution | |
| D36-11220A | In distribution | |
| NAC001-02 | In distribution | |
| M200 | In distribution | |
| B9-15323E | In distribution | |
| BGI-18792 | In distribution | |
| D36-15961 | In distribution | |
| B9-19704 | In distribution | |
| BMET-19019 | In distribution | |
| L4000-19622 | In distribution | |
| M400 | In distribution | |
| 38803015 | In distribution | |
| B446MM-B | In distribution | |
| BRSC-16374-1 | In distribution | |
| YMDCK-500A | In distribution | |
| KM19507 | In distribution | |
| B9-16706 | In distribution | |
| B9-15323D | In distribution | |
| 4082-1 | In distribution | |
| B9-17471 | In distribution | |
| MSK-17107 | In distribution | |
| ALEX-10480A | In distribution | |
| 3404922 | In distribution | |
| A3-15679 | In distribution | |
| B9-17934 | In distribution | |
| B9-15323B | In distribution | |
| B9-10803 | In distribution | |
| B9-16719 | In distribution | |
| UNC-10003 | In distribution | |
| UC-11384A | In distribution | |
| 3404253A | In distribution | |
| B9-16938A | In distribution | |
| S1528C | In distribution | |
| B9-4000 | In distribution | |
| CUS1871 | In distribution | |
| BCD-15690 | In distribution | |
| 5026CL-14 | In distribution | |
| NINE003 | In distribution | |
| KM5071 | In distribution | |
| OSC-16630 | In distribution | |
| B9-18863 | In distribution | |
| A3-15995 | In distribution | |
| B9-10022A | In distribution | |
| NHC-16673 | In distribution | |
| MWM-18937 | In distribution | |
| NINE004 | In distribution | |
| B9-19629 | In distribution | |
| KIT6873011 | In distribution | |
| D40-11262 | In distribution | |
| PSG100CO-3 | In distribution | |
| ZZ-0960 | In distribution | |
| UNC-9470 | In distribution | |
| JPK-19181 | In distribution | |
| NINE007 | In distribution | |
| CUS1207-01 | In distribution | |
| D40-11261 | In distribution | |
| MANN-18617 | In distribution | |
| UVA-17915 | In distribution | |
| UNC-9525A | In distribution | |
| L4000 | In distribution | |
| YMUAC-PARK11 | In distribution | |
| PCK-18014A | In distribution | |
| 38803016 | In distribution | |
| L2000 | In distribution | |
| UNC-10884 | In distribution | |
| YMUTS-CIR35 | In distribution | |
| PAK-19245 | In distribution | |
| OAZ-19069 | In distribution | |
| B9-17667 | In distribution | |
| D8-9560B | In distribution | |
| NINE002 | In distribution | |
| UNC-14685 | In distribution | |
| CUS1173 | In distribution | |
| ZZ-0683 | In distribution | |
| TRAPJT-1110 | In distribution | |
| B9-18339 | In distribution | |
| KM34052226 | In distribution | |
| CHC-19139 | In distribution | |
| UNC-17795 | In distribution | |
| B9-16715 | In distribution | |
| NINE006 | In distribution | |
| CHM-10971 | In distribution | |
| IHI-19697 | In distribution | |
| UNC-9469 | In distribution | |
| UNC-9534A | In distribution | |
| D6-19461 | In distribution | |
| UNC-10432C | In distribution | |
| M200-19756 | In distribution | |
| B9-15633B | In distribution | |
| D36-10676 | In distribution | |
| 02-104CL-4 | In distribution | |
| YMCIR-400 | In distribution | |
| 14935-B | In distribution | |
| L1000-19275 | In distribution | |
| B9-17738 | In distribution | |
| B9-16938 | In distribution | |
| L1000-19316 | In distribution | |
| B9-15903B | In distribution | |
| 0503A | In distribution | |
| R1542 | In distribution | |
| VA-102 | In distribution | |
| D40-11262 | In distribution | |
| CUS1174 | In distribution | |
| UNC-9471 | In distribution | |
| B9-19701 | In distribution | |
| M200-19733 | In distribution | |
| D36-7532 | In distribution | |
| ALEX-10482A | In distribution | |
| TRAPJTD-1110/1507 | In distribution | |
| SIG-100 | In distribution | |
| B3-17092 | In distribution | |
| RAC-300 | In distribution | |
| UNC-14666 | In distribution | |
| JPK-19181 2 | In distribution | |
| B9-19750 | In distribution | |
| B9-15934B | In distribution | |
| MWM-18364C | Withdrawn | |
| 3404253 | Withdrawn |
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.