Cardinal Health
Hfhs Anterior Cerv Fusion PK 1
1manufacturer
25,194catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | OJG |
| Device type | Neurological Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 882.4525 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-24 |
| 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 3, case of 4, case of 10, case of 6 |
| Distribution end date | 2017-10-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SNEOCLPUC8 | In distribution | |
| PN24SHLCM | In distribution | |
| PNVMNEBLR | In distribution | |
| SNE40CSJU1 | In distribution | |
| SNECGCRRIG | In distribution | |
| SNE81CRN21 | In distribution | |
| SNE69LME11 | In distribution | |
| SNE11LPNBI | In distribution | |
| SNE11CRHK9 | In distribution | |
| SNE41SPHSO | In distribution | |
| SNE32TYID2 | In distribution | |
| SNE13LMBI9 | In distribution | |
| SNE11CPHLH | In distribution | |
| SNECGCPCO4 | In distribution | |
| PN11NEXXE | In distribution | |
| PNHDCRMMC | In distribution | |
| SNE13LLBW7 | In distribution | |
| SNEOCNPGHB | In distribution | |
| SNE41CPTEC | In distribution | |
| SNE11CRHKV | In distribution | |
| SNEBCNRCH4 | In distribution | |
| PNVXNSL13 | In distribution | |
| PN23SPAM3 | In distribution | |
| PNHDOTV12 | In distribution | |
| SNE69LMSPA | In distribution | |
| SNE44SPSL3 | In distribution | |
| PN60SKMK1 | In distribution | |
| SOP45ASA14 | In distribution | |
| SNEOCNRLW5 | In distribution | |
| SNE23SNPR9 | In distribution | |
| 26A6667J | In distribution | |
| SNE11NRU35 | In distribution | |
| PNV2OT102 | In distribution | |
| SNENU0866P | In distribution | |
| SNECGACGC7 | In distribution | |
| PN55NSKC9 | In distribution | |
| PN23SPCAB | In distribution | |
| SNEHDSPSBO | In distribution | |
| SNE41LPJA2 | In distribution | |
| PN41LMMYE | In distribution | |
| PNOCLMA314 | In distribution | |
| SNE7CSFGR3 | In distribution | |
| SNE3LLAAHK | In distribution | |
| SNE69SPZCH | In distribution | |
| 27-2907C | In distribution | |
| SNE33CNCA6 | In distribution | |
| SNE7CSFGR7 | In distribution | |
| SNECGCRRIH | In distribution | |
| SNE37BSHN1 | In distribution | |
| SNE41KPAW1 | In distribution | |
| PN11CRLH1 | In distribution | |
| SNE69LMKBP | In distribution | |
| SNE23CSDUS | In distribution | |
| SNEW1ACHFN | In distribution | |
| SNE22RNMRD | In distribution | |
| SNE7CSHYN1 | In distribution | |
| PN60VP07I | In distribution | |
| SNE23KSARH | In distribution | |
| SNE53SPOR7 | In distribution | |
| PNVNAS09Y | In distribution | |
| PNOCCRM358 | In distribution | |
| PN33CFAD4 | In distribution | |
| SNE43BNN12 | In distribution | |
| PNOCCRSHT | In distribution | |
| SNEHDSPKPJ | In distribution | |
| PNVNCR921 | In distribution | |
| PNCGSPCDX | In distribution | |
| SNE37NRBS2 | In distribution | |
| SNE12BSKG6 | In distribution | |
| SNE69SPK15 | In distribution | |
| PN21MNEG7 | In distribution | |
| SNE23NTPHP | In distribution | |
| PN41SPLA1 | In distribution | |
| SNE23NBRW5 | In distribution | |
| SNE40CRJ23 | In distribution | |
| SNE48STLVH | In distribution | |
| SNEDHBNCHG | In distribution | |
| SNE51CR016 | In distribution | |
| SNE73CNTV5 | In distribution | |
| SNE40CMCFD | In distribution | |
| SNE40VSJUK | In distribution | |
| SNE25NECH5 | In distribution | |
| PN43KSUS1 | In distribution | |
| PN23SPA19 | In distribution | |
| SNE12CR38N | In distribution | |
| SNE13NRRUL | In distribution | |
| SNE12SPH10 | In distribution | |
| PNCGNDA16 | In distribution | |
| PN4JNECBC | In distribution | |
| PNHFMNMHO | In distribution | |
| SNE44SPTCG | In distribution | |
| SNE56SPP12 | In distribution | |
| SNE21CRNS9 | In distribution | |
| SNE43LNOGI | In distribution | |
| PNCGNPA10 | In distribution | |
| POVMDBBW5 | In distribution | |
| SNE44NRUSD | In distribution | |
| SNE32CR921 | In distribution | |
| PNOCVPBL9 | In distribution | |
| PNOCCY09N | In distribution | |
| PN41CLHMP | In distribution | |
| SNE1DCRU13 | In distribution | |
| SLP11LPSCD | In distribution | |
| PNOCNUJOQ | In distribution | |
| SNE2ANPCOK | In distribution | |
| SNE13VSMG8 | In distribution | |
| SNE18VSA18 | In distribution | |
| SNECGLPSB7 | In distribution | |
| SNE73SPCR3 | In distribution | |
| SNE31CNNW5 | In distribution | |
| SNE45NUWC3 | In distribution | |
| SNE44CNUTC | In distribution | |
| PNVMCY22Y | In distribution | |
| SNE11LMEN5 | In distribution | |
| SNE23CR52D | In distribution | |
| SNE54LAUCA | In distribution | |
| SNE57DN001 | In distribution | |
| SNECGVPR20 | In distribution | |
| SNE12BSK21 | In distribution | |
| SNE29CRM10 | In distribution | |
| SNE73NCPMH | In distribution | |
| PNOCOTPFN | In distribution | |
| SNE14LMRGN | In distribution | |
| SNE21SPAR6 | In distribution | |
| SNE41NPBCD | In distribution | |
| SNEOCCCH11 | In distribution | |
| SNE22NSM10 | In distribution | |
| PNCGACA20 | In distribution | |
| SNE15SSFSM | In distribution | |
| SNE73CRSJJ | In distribution | |
| SNE18LMEH1 | In distribution | |
| PN11NEXX6 | In distribution | |
| SNE12SPH11 | In distribution | |
| SNE54NLUMH | In distribution | |
| PN15LSR19 | In distribution | |
| SNE38BFSVA | In distribution | |
| SNE33LMOO8 | In distribution | |
| PNVQCY035 | In distribution | |
| SNE44CRVAH | In distribution | |
| SNE23CRMUY | In distribution | |
| SANOCNRRTG | In distribution | |
| SNE21LMEAT | In distribution | |
| SNE41LAUS2 | In distribution | |
| PNVZCRMF2 | In distribution | |
| PNMHACBHS | In distribution | |
| SNEOCLMH10 | In distribution | |
| SNE41FSCRA | In distribution | |
| PNV201016 | In distribution | |
| SNE26KYHR2 | In distribution | |
| SNE12CRHF8 | In distribution | |
| PNVMOT265 | In distribution | |
| SNE23CRP10 | In distribution | |
| PNMVLMUC2 | In distribution | |
| SNE11LMHKP | In distribution | |
| SNE73NECHJ | In distribution | |
| SNE13CRBW6 | In distribution | |
| SNE33VAAD3 | In distribution | |
| SNE63NESE7 | In distribution | |
| SNEOCNPN10 | In distribution | |
| PN33CROU2 | In distribution | |
| SNE40VSJU2 | In distribution | |
| SNE40NOMS2 | In distribution | |
| SNE73ZCTAH | In distribution | |
| SNE81ACNMQ | In distribution | |
| SNE57DNOH8 | In distribution | |
| PNV2SH310 | In distribution | |
| PNOCCYV20 | In distribution | |
| SNE7CCRY18 | In distribution | |
| PN14NSU12 | In distribution | |
| SNE11SPJ41 | In distribution | |
| PNCGCAC11 | In distribution | |
| PN11SFSS5 | In distribution | |
| SNE45NOCKE | In distribution | |
| PNVNAS905 | In distribution | |
| SNE13NRRU3 | In distribution | |
| SNE36HSCH1 | In distribution | |
| SNE11ECR11 | In distribution | |
| SNEOCCRHNE | In distribution | |
| SNE81ACNMJ | In distribution | |
| SNE11NBCPU | In distribution | |
| SNE45CRDHW | In distribution | |
| SNE69LAFH1 | In distribution | |
| SNE43NTOFI | In distribution | |
| SNE69CRCIY | In distribution | |
| SNE23LMVD8 | In distribution | |
| PN60VP07K | In distribution | |
| SNE43LPICC | In distribution | |
| PN60CRCL3 | In distribution | |
| PNV2LM018 | In distribution | |
| SNE51AAUSI | In distribution | |
| PNCGCNAUM | In distribution | |
| SNE3LAHCR3 | In distribution | |
| PP29CRCC5 | In distribution | |
| PN47CY796 | In distribution | |
| PN41LMS11 | In distribution | |
| PNVMNI223 | In distribution | |
| POX4SIPR1 | In distribution | |
| SNE11LMH24 | In distribution | |
| PNVMNI230 | In distribution | |
| SNE12SPH15 | In distribution | |
| SNECGCPMEA | In distribution | |
| SNE33NROUC | In distribution | |
| PNHDFSVC7 | In distribution | |
| PNOCLM129 | In distribution | |
| SNE69LMEC4 | In distribution | |
| SNE12LM343 | In distribution | |
| PNVNCR910 | In distribution | |
| SNE11CR429 | In distribution | |
| SNEHDCRBVC | In distribution | |
| SNE23NC927 | In distribution | |
| SNE13SW510 | In distribution | |
| SNE54SPWME | In distribution | |
| SNE73CRKF4 | In distribution | |
| SNE31VP161 | In distribution | |
| SNE41ACPR6 | In distribution | |
| PNVMCY240 | In distribution | |
| SNE41LAUSC | In distribution | |
| SNE57LM808 | In distribution | |
| PN24NSASJ | In distribution | |
| SNE33SPO14 | In distribution | |
| PN40CRSLV | In distribution | |
| SNECGVPR30 | In distribution | |
| SNEHDSPKP6 | In distribution | |
| SNE23C1137 | In distribution | |
| SNEVXCLCCD | In distribution | |
| PN29NN871 | In distribution | |
| SNE44OBSEB | In distribution | |
| PNJVNJMM2 | In distribution | |
| PNOCCFFGM | In distribution | |
| SNE69TRWH1 | In distribution | |
| PNOCNLWR7 | In distribution | |
| SNE12LN326 | In distribution | |
| SNE3LSPMH7 | In distribution | |
| SNE63NESEG | In distribution | |
| SNE11DKRHM | In distribution | |
| SNE19PCUWC | In distribution | |
| SNE81CRNM9 | In distribution | |
| PN11CLS12 | In distribution | |
| SANV1NIYH9 | In distribution | |
| PNCGNEBL7 | In distribution | |
| SNE57NP00B | In distribution | |
| PNCGCR662 | In distribution | |
| PNOCLMA310 | In distribution | |
| PNVMTR22G | In distribution | |
| PNVNAS903 | In distribution | |
| SNE5DCRFA4 | In distribution | |
| SNE13CRBW9 | In distribution | |
| SNE12SPHM1 | In distribution | |
| PNVNSPBCH5 | In distribution | |
| SNEHDLASPA | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 3,084 |
| Avid TruCustom | Avid Medical, Inc. | 969 |
| ACS | American Contract Systems, Inc. | 938 |
| Halyard | Avid Medical, Inc. | 718 |
| Regard™ | ROi CPS LLC | 208 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 55 |
| Aligned Medical Solutions | Aligned Medical Solutions | 53 |
| V. Mueller | Steris Corporation | 27 |
| Nico BrainPath Approach | Nico Corporation | 25 |
| V. Mueller | Carefusion 2200, Inc. | 13 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 11 |
| Phasor | Phasor Health, LLC | 8 |
Showing 12 of 24. All products under Neurological Tray
Recalls Naming This Product
16 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 | 645 units |
| Cardinal Health 200, LLC | UDI-DI | 2026-07-14 | Class II | Nonconforming Material/Component | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | 36862 kits |
| Cardinal Health 200, LLC | UDI-DI | 2026-07-14 | Class II | Nonconforming Material/Component | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | 87182 kits |
| Cardinal Health 200, LLC | UDI-DI | 2026-07-14 | Class II | Nonconforming Material/Component | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | 602 kits |
| Cardinal Health 200, LLC | UDI-DI | 2026-07-14 | Class II | Nonconforming Material/Component | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | 401311 kits |
| Cardinal Health 200, LLC | UDI-DI | 2026-07-14 | Class II | Nonconforming Material/Component | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | 52699 kits |
| Cardinal Health 200, LLC | UDI-DI | 2026-07-14 | Class II | Nonconforming Material/Component | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | 616 kits |
| 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 | 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 | 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 |
| 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 |
| 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 |
| 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. | 793,785 total units |
| Cardinal Health 200, LLC | UDI-DI | 2024-05-29 | Class II | Device Design | Cardinal Health is following the FDA’s recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are i | 13487 units |
| Cardinal Health 200, LLC | UDI-DI | 2023-08-16 | Class II | Material/Component Contamination | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). | 13,351 total packs |
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.