ACS
Standard Trinity C-Section PK W/O Drape
3manufacturers in China registered for this device type
533catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Anhui (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medical Sterilizing Co., Ltd. | Hefei | Anhui | Contract manufacturer | 8 |
Record
| Listed by | American Contract Systems, Inc. |
|---|---|
| FDA product code | OHM |
| Device type | Cesarean Section Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Premarket notification | Exempt |
| Record published | 2022-12-20 |
| Record revised | 2022-06-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FDCS01AA | In distribution | |
| GBCS14D | In distribution | |
| BHCS88D | In distribution | |
| MMCS01B | In distribution | |
| BLBC23H | In distribution | |
| ISCS25I | In distribution | |
| GRCS34V | In distribution | |
| MRCS18P | In distribution | |
| LLCS44E | In distribution | |
| UICS50AD | In distribution | |
| HCCS06I | In distribution | |
| AHCS26Y | In distribution | |
| AHCS77W | In distribution | |
| AMCS20AB | In distribution | |
| BLBC23J | In distribution | |
| GOCS34D | In distribution | |
| JTCS12D | In distribution | |
| MHCS55G | In distribution | |
| FYCS41E | In distribution | |
| CFCS39G | In distribution | |
| SECS02E | In distribution | |
| MRCS18O | In distribution | |
| RBCS12T | In distribution | |
| RCFV12A | In distribution | |
| JECS02Q | In distribution | |
| SMCS22O | In distribution | |
| JRCS44H | In distribution | |
| WVCS02I | In distribution | |
| MKCS43I | In distribution | |
| GRCS34P | In distribution | |
| AKCS54E | In distribution | |
| WECS27F | In distribution | |
| SWCS92M | In distribution | |
| AHCS77Q | In distribution | |
| LMCS21U | In distribution | |
| SLCS09L | In distribution | |
| LSRCUSCSECTH | In distribution | |
| FBCS38K | In distribution | |
| TMCS10E | In distribution | |
| RCCS18A | In distribution | |
| FRCS71AD | In distribution | |
| CICS45H | In distribution | |
| HSCB90B | In distribution | |
| PRCS11V | In distribution | |
| CXCS92S | In distribution | |
| AHCS38B | In distribution | |
| WECS27B | In distribution | |
| EVCS35J | In distribution | |
| MMCS01D | In distribution | |
| AHCS26Z | In distribution | |
| HSCS64O | In distribution | |
| GRCS34S | In distribution | |
| HSCS64L | In distribution | |
| MMCS34G | In distribution | |
| EVCS35B | In distribution | |
| HGCS68I | In distribution | |
| JECS02O | In distribution | |
| CACS20G | In distribution | |
| ATCS03W | In distribution | |
| SMCS22J | In distribution | |
| FRCS71AE | In distribution | |
| HWCS01V | In distribution | |
| FDCS01AB | In distribution | |
| EFCG39A | In distribution | |
| AHCS38A | In distribution | |
| MCCS42A | In distribution | |
| CECS03I | In distribution | |
| OSCS16B | In distribution | |
| CACS20E | In distribution | |
| OLCS34B | In distribution | |
| WHCS03G | In distribution | |
| PLCS46G | In distribution | |
| AHCS50AD | In distribution | |
| LLCI66L | In distribution | |
| WVCS02L | In distribution | |
| GOCS34E | In distribution | |
| JTCS12E | In distribution | |
| MCCS42C | In distribution | |
| MECS09V | In distribution | |
| HZCS44C | In distribution | |
| CECS03H | In distribution | |
| SBCS11W | In distribution | |
| COCS59K | In distribution | |
| FICS05M | In distribution | |
| FICS05P | In distribution | |
| AUCS33F | In distribution | |
| OSCS16D | In distribution | |
| FDCS01X | In distribution | |
| GOCS34G | In distribution | |
| BRCS04O | In distribution | |
| HSCS64M | In distribution | |
| BLCS22L | In distribution | |
| MSCS51B | In distribution | |
| CECS03P | In distribution | |
| FBCS38L | In distribution | |
| WVCS02O | In distribution | |
| ASCS38A | In distribution | |
| AKCS54D | In distribution | |
| LKCS09W | In distribution | |
| MHCS82B | In distribution | |
| SECS02D | In distribution | |
| AHCS50AG | In distribution | |
| LKCS09U | In distribution | |
| AMCS20Y | In distribution | |
| AHCS50AE | In distribution | |
| FRCS71Y | In distribution | |
| SACS76Z | In distribution | |
| YOCS20P | In distribution | |
| LACT85F | In distribution | |
| BDCS31A | In distribution | |
| KPCS19N | In distribution | |
| SMCS51A | In distribution | |
| HSCB90A | In distribution | |
| HGCS68H | In distribution | |
| LUCS01H | In distribution | |
| KPCS19M | In distribution | |
| ISCS25F | In distribution | |
| SGCS33A | In distribution | |
| CDOB98H | In distribution | |
| RCFV12D | In distribution | |
| HOCS20B | In distribution | |
| BLBC23I | In distribution | |
| LLCI66J | In distribution | |
| ISCS25H | In distribution | |
| KDCS11E | In distribution | |
| MMCC16I | In distribution | |
| JOCS21E | In distribution | |
| FHCP08Z | In distribution | |
| IHCS29AA | In distribution | |
| UICS50AC | In distribution | |
| GRCS34O | In distribution | |
| FRCS71AC | In distribution | |
| AHCS38C | In distribution | |
| SMCS04N | In distribution | |
| JECS02N | In distribution | |
| RBCS12U | In distribution | |
| ROCS82D | In distribution | |
| UICS50AB | In distribution | |
| DFCS45E | In distribution | |
| CXCS92T | In distribution | |
| KDCS11D | In distribution | |
| BHCS31K | In distribution | |
| HBCS10F | In distribution | |
| LLCS44G | In distribution | |
| MYCS24C | In distribution | |
| SVCB15C | In distribution | |
| HOCS20C | In distribution | |
| LMSE38M | In distribution | |
| SBCS11V | In distribution | |
| YOCS20O | In distribution | |
| SMCS22M | In distribution | |
| HICS50F | In distribution | |
| HICS50G | In distribution | |
| AHCS26AA | In distribution | |
| SECS02G | In distribution | |
| AHCS50Z | In distribution | |
| BHCS88E | In distribution | |
| MCCS46H | In distribution | |
| COCS59J | In distribution | |
| GOCS34H | In distribution | |
| HSCS64K | In distribution | |
| CACS20F | In distribution | |
| OSCS16C | In distribution | |
| FTCS14M | In distribution | |
| WNCS18R | In distribution | |
| PRCS11T | In distribution | |
| EFCG39C | In distribution | |
| ROCS82B | In distribution | |
| LUCS01G | In distribution | |
| LLCI66M | In distribution | |
| AHCS38E | In distribution | |
| EVCS35E | In distribution | |
| ALCS53D | In distribution | |
| RBCB11I | In distribution | |
| OSCS16E | In distribution | |
| PRCS03O | In distribution | |
| SVCS66J | In distribution | |
| CACS51G | In distribution | |
| MSCS51A | In distribution | |
| FTCT19F | In distribution | |
| GRCS34T | In distribution | |
| AKCS54A | In distribution | |
| LLCS44C | In distribution | |
| AHCS38F | In distribution | |
| THCS49A | In distribution | |
| GRCS34U | In distribution | |
| JECS02P | In distribution | |
| FTCS14S | In distribution | |
| CECS03K | In distribution | |
| THCS49B | In distribution | |
| BLCS22O | In distribution | |
| AHCS77T | In distribution | |
| TNSC15I | In distribution | |
| FRCS71X | In distribution | |
| AHCS26X | In distribution | |
| LLCS44D | In distribution | |
| MMCS01G | In distribution | |
| ASCS38B | In distribution | |
| HOCS20D | In distribution | |
| UICS50X | In distribution | |
| MKCS43G | In distribution | |
| FRCS43I | In distribution | |
| LBCS31Q | In distribution | |
| CZCS99A | In distribution | |
| IHCS29AF | In distribution | |
| CICS45J | In distribution | |
| AUCS33G | In distribution | |
| WVCS02M | In distribution | |
| ALCS53B | In distribution | |
| FTCS14K | In distribution | |
| MCCS46I | In distribution | |
| MPCS72J | In distribution | |
| CECS59J | In distribution | |
| EVCS35F | In distribution | |
| LMCS02O | In distribution | |
| LMCS02R | In distribution | |
| CZCS99B | In distribution | |
| MECS09U | In distribution | |
| AUCS33D | In distribution | |
| IHCS29AC | In distribution | |
| IHCS29AB | In distribution | |
| BHCS31J | In distribution | |
| FRCS71Z | In distribution | |
| LMCS21S | In distribution | |
| JNCS64A | In distribution | |
| JRCS44I | In distribution | |
| HOCS20G | In distribution | |
| GRCS34R | In distribution | |
| GNCS03J | In distribution | |
| ISCS25J | In distribution | |
| NLCS65B | In distribution | |
| AHCS50AH | In distribution | |
| EVCS35I | In distribution | |
| EVCS35C | In distribution | |
| JOCS21F | In distribution | |
| AHCS50AA | In distribution | |
| ESCS35B | In distribution | |
| WVCS02N | In distribution | |
| LMCS21R | In distribution | |
| HSCS64N | In distribution | |
| SECS02F | In distribution | |
| AHCS77U | In distribution | |
| ISCS25E | In distribution | |
| RWCS71I | In distribution | |
| CECS03L | In distribution | |
| JOCS21G | In distribution | |
| MECS09W | In distribution | |
| SHCS30E | In distribution | |
| FDCS01Z | In distribution | |
| OLCS34A | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 7,091 |
| Medline Industries, Inc. | Medline Industries, Inc. | 5,487 |
| Regard™ | ROi CPS LLC | 78 |
| DeRoyal | Deroyal Industries, Inc. | 32 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 32 |
| Medline | Medline Industries, Inc. | 7 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 6 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 6 |
| Aligned Medical Solutions | Aligned Medical Solutions | 3 |
| Henry Schein | Henry Schein, Inc. | 2 |
| Halyard | Avid Medical, Inc. | 2 |
| Invenio | GRI-Alleset, Inc. | 1 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| American Contract Systems, Inc. | UDI-DI | 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 252 kits |
| American Contract Systems, Inc. | UDI-DI | 2025-02-06 | Class II | Process control | ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment. | 1106 kits |
| American Contract Systems, Inc. | UDI-DI | 2023-11-29 | Class II | Process control | During an internal investigation, ACS identified that several components were “piggybacked” to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the “piggybacked” components were assessed | 1818 units |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2025-09-04 | Class II | Nonconforming Material/Component | Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycle | 32,433 total | |
| 2022-06-16 | Class II | Process change control | Product was exposed to multiple sterilization cycles without validation for multiple exposures. | 24 units | |
| 2020-04-13 | Class II | Process control | The surgical gowns were manufactured in a facility that is not registered by the FDA. | 2868 total kits | 2020-11-25 |
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.