Cardinal Health
Kit,maxillofacial Presbyterian
7manufacturers in China registered for this device type
813catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | OFX |
| Device type | General Purpose Dental Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-07-29 |
| 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 |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 2, case, case of 4, case of 3, case of 6, case of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SEN11DML13 | In distribution | |
| SEN13OPBCB | In distribution | |
| SEN12DBUVA | In distribution | |
| SEN11DNLD9 | In distribution | |
| SEN23DND17 | In distribution | |
| SEN59DEFHB | In distribution | |
| SENDHDPNH2 | In distribution | |
| SEN23DNDUU | In distribution | |
| PWV2MF01E | In distribution | |
| PE42DNTMK | In distribution | |
| SEN23PDNLA | In distribution | |
| SEN44OPSC1 | In distribution | |
| SEN33DLCA1 | In distribution | |
| SEN11DNLDI | In distribution | |
| SENHDDTMMA | In distribution | |
| SENMHDTBHJ | In distribution | |
| PWV2MF10S | In distribution | |
| SEN12DTROJ | In distribution | |
| SEN23DENLA | In distribution | |
| SEN23DPNVA | In distribution | |
| SEN11DPCH3 | In distribution | |
| PECGDNRO9 | In distribution | |
| SEN08DSCHB | In distribution | |
| PWV2MFCPE | In distribution | |
| PEOCDNBLH | In distribution | |
| PECGDNR19 | In distribution | |
| PECGDNRO4 | In distribution | |
| PECGDNR17 | In distribution | |
| PE35DTCH6 | In distribution | |
| SEN11OSCHE | In distribution | |
| SEN45DPANF | In distribution | |
| SEN12DNYH4 | In distribution | |
| SEN40DECFB | In distribution | |
| PECGDNR14 | In distribution | |
| SENCGDTFHC | In distribution | |
| SEN08DSCHE | In distribution | |
| PEDHMOWOH | In distribution | |
| SEN08DSCHF | In distribution | |
| SENOCDOUC4 | In distribution | |
| SEN23DPPCD | In distribution | |
| SEN23DPPCE | In distribution | |
| SEN24DNLCI | In distribution | |
| SENHDDPTSA | In distribution | |
| SEN45OSEAK | In distribution | |
| SEN6EDPVCB | In distribution | |
| PE08MXG24 | In distribution | |
| SEN23DND13 | In distribution | |
| SEN23DND16 | In distribution | |
| SENCGOMFHB | In distribution | |
| SEN33OROUK | In distribution | |
| SEN45DNCDB | In distribution | |
| SEN42DPIAA | In distribution | |
| PE35DNBL1 | In distribution | |
| SEN23DNDU7 | In distribution | |
| SEN11DNHHM | In distribution | |
| SEN12DNYH1 | In distribution | |
| SEN13DEET4 | In distribution | |
| SEN23DENLC | In distribution | |
| PE08MXG10 | In distribution | |
| PEDHMOWOF | In distribution | |
| SEN45OSEAN | In distribution | |
| SEN33WDCHF | In distribution | |
| SENDHDPNHC | In distribution | |
| SENDHDPNH7 | In distribution | |
| SEN13DPBCC | In distribution | |
| SENDKDNFL1 | In distribution | |
| SEN23DPNVB | In distribution | |
| SEN12DNYHE | In distribution | |
| SEN23DND10 | In distribution | |
| SENHDDPVC6 | In distribution | |
| SENHFDPSJ6 | In distribution | |
| PE08MXGH2 | In distribution | |
| SENCGDTFHI | In distribution | |
| SENCGDPACA | In distribution | |
| SEN44OPSC3 | In distribution | |
| SEN11DMLDK | In distribution | |
| SEN11OSJ11 | In distribution | |
| SEN41DNMAA | In distribution | |
| SEN33WDCHB | In distribution | |
| SEN11DNJHJ | In distribution | |
| SEN11DBCPP | In distribution | |
| SENHFDPSJD | In distribution | |
| SEN11DNHHF | In distribution | |
| SENHDDPVCC | In distribution | |
| PWV2MF018 | In distribution | |
| SEN11OSJHC | In distribution | |
| SEN14DTCHI | In distribution | |
| SEN33OROUC | In distribution | |
| PEDHMOWO1 | In distribution | |
| SEN53DEVS1 | In distribution | |
| SEN23DRTUE | In distribution | |
| PECGDNRO5 | In distribution | |
| SEN59DEFHC | In distribution | |
| SEN23ENMUU | In distribution | |
| SEN11DPNSP | In distribution | |
| SBA23DTASD | In distribution | |
| SEN11DNJHI | In distribution | |
| PECGDNROJ | In distribution | |
| SEN7CPDYN3 | In distribution | |
| PECGDNROE | In distribution | |
| SEN23DPDUB | In distribution | |
| SENCGPDNO2 | In distribution | |
| SENOCDOUC6 | In distribution | |
| SEN33WDCHC | In distribution | |
| SENOCDTBR2 | In distribution | |
| SEN12DTRO4 | In distribution | |
| SEN11DBCPK | In distribution | |
| PE35DNBLA | In distribution | |
| SEN24DEJMA | In distribution | |
| SEN40OSJU9 | In distribution | |
| SENOCDOUC5 | In distribution | |
| SEN11DML11 | In distribution | |
| SEN11DNHHH | In distribution | |
| SENVMDPSCB | In distribution | |
| PWV2MF110 | In distribution | |
| SEN45DRDHC | In distribution | |
| SENHFDPSJ4 | In distribution | |
| SEN55DPTAC | In distribution | |
| SEN21DEDC1 | In distribution | |
| SEN40OSJUC | In distribution | |
| SEN13DEETA | In distribution | |
| SEN08DSCHG | In distribution | |
| SEN23DND11 | In distribution | |
| PECGDNRO8 | In distribution | |
| SEN55DPTAB | In distribution | |
| DEN99DP1AA | In distribution | |
| SENCGDTFHK | In distribution | |
| SEN11DBCP4 | In distribution | |
| SEN53DEVSB | In distribution | |
| SENCGDEBOA | In distribution | |
| SEN33DPFPC | In distribution | |
| PECGDNRO3 | In distribution | |
| SEN59DPTCA | In distribution | |
| PE08MXGH7 | In distribution | |
| SEN11DEMMG | In distribution | |
| SEN11DMLDI | In distribution | |
| SEN40OSJUE | In distribution | |
| SENHDDPV13 | In distribution | |
| SEN35DEBL1 | In distribution | |
| SENDHDPCMC | In distribution | |
| SNE11DPC21 | In distribution | |
| PWV2MF016 | In distribution | |
| SENHFDPFTA | In distribution | |
| SEN23DNUCL | In distribution | |
| SEN11OSJH1 | In distribution | |
| SEN44OPSC7 | In distribution | |
| PE35DNBLC | In distribution | |
| SEN73OSVDD | In distribution | |
| PE35DTCH3 | In distribution | |
| PWV2MF10U | In distribution | |
| SENHDDPVCI | In distribution | |
| SEN11DNHH1 | In distribution | |
| SEN45OSEAD | In distribution | |
| SEN59DRANB | In distribution | |
| SENCGDPAB1 | In distribution | |
| SEN55DPTAA | In distribution | |
| PEOCDNBL6 | In distribution | |
| SENHDDTMM1 | In distribution | |
| SEN23DPNVC | In distribution | |
| PE08MXGHM | In distribution | |
| PE08MXGH3 | In distribution | |
| SEN23DEMLC | In distribution | |
| SEN35DEBLD | In distribution | |
| SEN45OSEAE | In distribution | |
| SEN13PDBTA | In distribution | |
| PECGDNR20 | In distribution | |
| SEN54DPUPB | In distribution | |
| SEN12DTROG | In distribution | |
| SENCGDTFHB | In distribution | |
| PE08MXGHT | In distribution | |
| SEN11DNHH3 | In distribution | |
| SEN4FOMFAA | In distribution | |
| SBA2ADTOHD | In distribution | |
| SEN12DNYHD | In distribution | |
| SEN11DBCP5 | In distribution | |
| PWV2MFCP3 | In distribution | |
| SEN11DNMMF | In distribution | |
| SEN44DNTCK | In distribution | |
| SEN73OSVD1 | In distribution | |
| SEN54DPUP3 | In distribution | |
| SENCGOMFHA | In distribution | |
| SEN40OSJU4 | In distribution | |
| SNE11DPCHX | In distribution | |
| PECGDNROG | In distribution | |
| SEN33ORO15 | In distribution | |
| SBAHDDTMMB | In distribution | |
| SEN56DPSCA | In distribution | |
| PE35DNBL9 | In distribution | |
| SENDHDPNHA | In distribution | |
| SENCGPDNO1 | In distribution | |
| SEN7CPDYNJ | In distribution | |
| SEN45OSEAA | In distribution | |
| SEN11DPNSN | In distribution | |
| PEHDDNHUD | In distribution | |
| SEN45OSEAL | In distribution | |
| SEN11DNJH5 | In distribution | |
| SEN11DPCH4 | In distribution | |
| PEOCDNBL2 | In distribution | |
| SEN23DEMLB | In distribution | |
| SEN24DNLCH | In distribution | |
| SENCGDTFHM | In distribution | |
| SEN54WDSJA | In distribution | |
| SEN41DPRSC | In distribution | |
| SEN11DMLD3 | In distribution | |
| PE35DNB12 | In distribution | |
| PWV2MF021 | In distribution | |
| SEN11DMLD4 | In distribution | |
| SENDKDNFLB | In distribution | |
| SENHDDPV16 | In distribution | |
| PWV2MF109 | In distribution | |
| PWV2MFCP4 | In distribution | |
| SEN12DBUV1 | In distribution | |
| SEN11DNLDJ | In distribution | |
| SEN54WDSJD | In distribution | |
| PE42DNTMM | In distribution | |
| PEHDDNHUC | In distribution | |
| SEN69DPKR1 | In distribution | |
| SEN54DPUP2 | In distribution | |
| PWV2MF011 | In distribution | |
| PE35DNBL3 | In distribution | |
| SEN23DPCLA | In distribution | |
| PE08MXGHP | In distribution | |
| SENMIOSUMA | In distribution | |
| SEN44OPSC6 | In distribution | |
| SEN13DEET5 | In distribution | |
| SEN08DNCHI | In distribution | |
| SEN38DPMH1 | In distribution | |
| SENCGOMFHC | In distribution | |
| PWV2MF105 | In distribution | |
| DEN99DP2AA | In distribution | |
| SENMHDTBH4 | In distribution | |
| SENHFDPFTB | In distribution | |
| SENDKDNFLC | In distribution | |
| SEN21DEDCD | In distribution | |
| SEN54DPUP1 | In distribution | |
| SENOCDNSLC | In distribution | |
| SEN11DNLD3 | In distribution | |
| SENHDDPVC1 | In distribution | |
| SENDHDPNHD | In distribution | |
| SEN23DRTUF | In distribution | |
| SENCGDTFHH | In distribution | |
| SEN23DXCW4 | In distribution | |
| SEN11DEMMF | In distribution | |
| SENHDDPVC7 | In distribution | |
| SENHDDPTSC | In distribution | |
| SENHDDTCHI | In distribution | |
| SEN21DEDCA | In distribution | |
| SEN13OPBCC | In distribution | |
| SEN11OSCHB | In distribution | |
| PE08MXG20 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 287 |
| Stradis Healthcare | Stradis Healthcare | 69 |
| Stradis | Stradis Healthcare | 44 |
| Aligned Medical Solutions | Aligned Medical Solutions | 25 |
| ACS | American Contract Systems, Inc. | 25 |
| Centurion | Centurion Medical Products Corporation | 21 |
| Medical Action Industries | Medical Action Industries, Inc. | 10 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 9 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 4 |
| DeRoyal | Deroyal Industries, Inc. | 3 |
| Regard™ | ROi CPS LLC | 2 |
| Henry Schein | Henry Schein, Inc. | 2 |
Showing 12 of 46. All products under General Purpose Dental Tray
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 |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2026-07-29 | Class II | Process change control | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These | 60 units |
| Cardinal Health 200, LLC | UDI-DI | 2024-11-08 | Class II | Nonconforming Material/Component | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | 512,786 total units |
| Cardinal Health 200, LLC | UDI-DI | 2024-11-08 | Class II | Material/Component Contamination | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | 973,785 total units |
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.