Cardinal Health
6.5 & 7.3mm Cannulated Screw System Graphic Case Assembly
1manufacturer
95,039catalogue numbers in this listing
5recalls 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 | OJH |
| Device type | Orthopedic Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-04-15 |
| Record revised | 2022-06-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| 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 5, case of 6 |
| Distribution end date | 2018-06-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SOP53EXPZ4 | In distribution | |
| SOP41EPUB6 | In distribution | |
| POV2TK26N | In distribution | |
| SOP37SHMF5 | In distribution | |
| SOP11HPHT2 | In distribution | |
| SOP32HAJ15 | In distribution | |
| SOP53APKPH | In distribution | |
| SOP21KATC5 | In distribution | |
| SOPOCHISWC | In distribution | |
| SOP21SPTN6 | In distribution | |
| SNE53ACMB3 | In distribution | |
| SOPMINTCHA | In distribution | |
| PN08APGHC8 | In distribution | |
| PO13AREMX | In distribution | |
| SOP56THTTA | In distribution | |
| SOP11AYS14 | In distribution | |
| SOP13KAELD | In distribution | |
| SOP41SDOCA | In distribution | |
| SOP24KASCC | In distribution | |
| SOP23SAHNB | In distribution | |
| SOP4FLENGB | In distribution | |
| SOP3SEPRGA | In distribution | |
| SOP37THPS5 | In distribution | |
| SOP41EPRW1 | In distribution | |
| SOP13KNSHN | In distribution | |
| SOP7CAAYNM | In distribution | |
| SOP22FTSM6 | In distribution | |
| SOPCGMOTR1 | In distribution | |
| POVXTHBM1 | In distribution | |
| PO43TSEJ1 | In distribution | |
| SOP69TKKF5 | In distribution | |
| PO30NRM27 | In distribution | |
| SOPCGDAO10 | In distribution | |
| SOPCGANAUC | In distribution | |
| SOPDHHRROE | In distribution | |
| SOP12HHYH9 | In distribution | |
| SOP73GAKMC | In distribution | |
| SOP33HIDW4 | In distribution | |
| SOP34TJLP5 | In distribution | |
| SOP43SDMA8 | In distribution | |
| SOPDKHPBSA | In distribution | |
| SOP69TSKB2 | In distribution | |
| SOP31HP914 | In distribution | |
| PO4EKAALE | In distribution | |
| SOP3LTHMHR | In distribution | |
| SOP32FAMEQ | In distribution | |
| SOP73KAKAA | In distribution | |
| POCGHNAA12 | In distribution | |
| PO22THMM5 | In distribution | |
| SOP41SPSU4 | In distribution | |
| SRI63SPUM3 | In distribution | |
| SBA32SCLML | In distribution | |
| SOP4ASSYNB | In distribution | |
| SOP3BCAFC2 | In distribution | |
| SOP54TKPOH | In distribution | |
| SOPCNHACYA | In distribution | |
| SOP31HPS23 | In distribution | |
| SOP81OPABC | In distribution | |
| SOP13MOSTC | In distribution | |
| CHIP99SA1C | In distribution | |
| SOP34APHF1 | In distribution | |
| SOP36TJSC2 | In distribution | |
| SOP31AKVNN | In distribution | |
| SOP3DEPMMG | In distribution | |
| SOP12PHFSO | In distribution | |
| SOP57ACBA1 | In distribution | |
| SOP29TKBVI | In distribution | |
| PODHTKPCB | In distribution | |
| SOP22PSMRE | In distribution | |
| SOP35PPCSD | In distribution | |
| POV2T01108 | In distribution | |
| SOPCGARPL4 | In distribution | |
| POCGAKAAUN | In distribution | |
| SOP21HIARC | In distribution | |
| SOP48AHLS3 | In distribution | |
| SOP14HSNY3 | In distribution | |
| SOP4ATK591 | In distribution | |
| SOPHDEXWDA | In distribution | |
| SOP41EXCO6 | In distribution | |
| POCGAPBS5 | In distribution | |
| PO41EXOKE | In distribution | |
| SOP43SAZA4 | In distribution | |
| SOP32ATJW1 | In distribution | |
| SOPCNWFKS3 | In distribution | |
| SOP73KEKS6 | In distribution | |
| PO45THVH8 | In distribution | |
| SOP57HDVA9 | In distribution | |
| SOP44CLT12 | In distribution | |
| POVMHTBHM | In distribution | |
| SOP43THARM | In distribution | |
| SOPMITKPSA | In distribution | |
| SOP48SANP2 | In distribution | |
| SOPHDKACA1 | In distribution | |
| SOP41LEUB5 | In distribution | |
| SOP48SANSM | In distribution | |
| PO33THOC2 | In distribution | |
| SOPMISPRCC | In distribution | |
| SOP41KAUN4 | In distribution | |
| SOP48OPMCA | In distribution | |
| POVMTK612 | In distribution | |
| SOP12APFSD | In distribution | |
| SOP23EXARK | In distribution | |
| SOPOCHPLBA | In distribution | |
| SOP12AHHFF | In distribution | |
| SOP37EXMFD | In distribution | |
| SOPMHKNFBP | In distribution | |
| SOPHFKAASA | In distribution | |
| SOP33SPGCA | In distribution | |
| SOP41ETSGB | In distribution | |
| SOP37EXMOC | In distribution | |
| SOP31ETCD5 | In distribution | |
| PO11TKS22 | In distribution | |
| SOP35BCCGH | In distribution | |
| PO30HMM12 | In distribution | |
| POVMSH210 | In distribution | |
| SOP42HPWCA | In distribution | |
| SOP56HP46J | In distribution | |
| SOPOCLECOA | In distribution | |
| POVMATBHF | In distribution | |
| SOP43SHPPI | In distribution | |
| SOP59TJFH1 | In distribution | |
| PO11TKS27 | In distribution | |
| SOP33HAPI8 | In distribution | |
| POCGTKARF | In distribution | |
| SOP54KSIO4 | In distribution | |
| SOP23HNRO3 | In distribution | |
| SOP21APRF5 | In distribution | |
| SOP35SACGK | In distribution | |
| SOPCGSHSCD | In distribution | |
| SOP32SPID8 | In distribution | |
| SOP73EXFV2 | In distribution | |
| SOP53MHEC1 | In distribution | |
| SOP33APCH4 | In distribution | |
| SOP4LSPBR6 | In distribution | |
| SOPCGSAIL4 | In distribution | |
| SOP53AHVMG | In distribution | |
| POVXTK510 | In distribution | |
| SOP29KAHC2 | In distribution | |
| SOP33EPN12 | In distribution | |
| SOP73ARKS6 | In distribution | |
| PO73THSIB | In distribution | |
| PO29TKSWE | In distribution | |
| SOP69KAKBH | In distribution | |
| SOP13HTCOM | In distribution | |
| SOP73TKIOA | In distribution | |
| SOP13KETMC | In distribution | |
| SOPHDEXBRA | In distribution | |
| SOP5CEPBN5 | In distribution | |
| SOP24HASCB | In distribution | |
| SOP41SAGV4 | In distribution | |
| SOP48KASU4 | In distribution | |
| SOP38PPSI4 | In distribution | |
| POOCTNBDO | In distribution | |
| SOPCGACSDG | In distribution | |
| SOP35KPBWL | In distribution | |
| SOP43LEMSC | In distribution | |
| PO41KPN15 | In distribution | |
| SOP41KSPHH | In distribution | |
| SOPOCTHWR2 | In distribution | |
| SOP43TPUS3 | In distribution | |
| PN4EBKAL7 | In distribution | |
| SOPMIFAN10 | In distribution | |
| SOP31ACOSS | In distribution | |
| POOCHDBDG | In distribution | |
| POOCTH645 | In distribution | |
| SOP23BK145 | In distribution | |
| SOP53FPG10 | In distribution | |
| POMHLXN11 | In distribution | |
| SOPHFHPS13 | In distribution | |
| SOPCGPPA19 | In distribution | |
| PN69MSGA8 | In distribution | |
| POCGARBLG | In distribution | |
| SOPCGEPPC1 | In distribution | |
| POG0FTCLL | In distribution | |
| SOP29KACCF | In distribution | |
| SOPHDUEVCC | In distribution | |
| SOP32LSGMK | In distribution | |
| SOP21KABA3 | In distribution | |
| SOP53TKCO8 | In distribution | |
| SOP23ORXF3 | In distribution | |
| SOP56GNLD2 | In distribution | |
| SOP7CAPYN3 | In distribution | |
| SOPOCHAASH | In distribution | |
| SOP73OSKSF | In distribution | |
| SOP30KBPRA | In distribution | |
| PO40SHSO2 | In distribution | |
| SOP69EPVPA | In distribution | |
| POCGTHCD4 | In distribution | |
| SOP11KAJK5 | In distribution | |
| SOP73APOPG | In distribution | |
| SOP11OSLH7 | In distribution | |
| POW1THW19 | In distribution | |
| PO40TKCFC | In distribution | |
| SOPHBAPTS3 | In distribution | |
| PO41TKMY8 | In distribution | |
| SOPOCHPWDF | In distribution | |
| SOP11TJJM6 | In distribution | |
| SOP12TJ01B | In distribution | |
| SOPHFHPOS4 | In distribution | |
| PO29SPSW2 | In distribution | |
| SOP13TKJB2 | In distribution | |
| SOP21UEHR6 | In distribution | |
| PO29THAGM | In distribution | |
| SOP31ERCD8 | In distribution | |
| CHIP99SA22 | In distribution | |
| SOP40MKJU2 | In distribution | |
| SOP19EXFA7 | In distribution | |
| SOP18OMA13 | In distribution | |
| PO33FAOCB | In distribution | |
| SOP21LLN12 | In distribution | |
| SOP32HNMNY | In distribution | |
| SOP44TKWPC | In distribution | |
| SOPOCHNL12 | In distribution | |
| SOP55AR63T | In distribution | |
| SOP12KNMF3 | In distribution | |
| SOPVXTSWH3 | In distribution | |
| PO11THL13 | In distribution | |
| SOP29FTSJM | In distribution | |
| POCGAABS9 | In distribution | |
| SOPCGPHLG2 | In distribution | |
| SOPCNPPBM1 | In distribution | |
| SOPHBSASRC | In distribution | |
| SOP55TJWMU | In distribution | |
| SOP59ACANE | In distribution | |
| POOCEXJOP | In distribution | |
| SOP53TKPSA | In distribution | |
| PO1DTKAME | In distribution | |
| SOP23SAHNA | In distribution | |
| PO1DTKAM4 | In distribution | |
| SOP42ARBTD | In distribution | |
| SOP21LECU5 | In distribution | |
| POV1OT666 | In distribution | |
| SOP4ATKHCJ | In distribution | |
| PO7ATJEC1 | In distribution | |
| PO11THASSX | In distribution | |
| SOP48KAN10 | In distribution | |
| PO40THKUI | In distribution | |
| PO4JTJHPB | In distribution | |
| SOP69CTFSK | In distribution | |
| SOP23LERCQ | In distribution | |
| SOPDHMFNHC | In distribution | |
| SOPMIKPRCB | In distribution | |
| SOP38KAMM1 | In distribution | |
| SOP41TJAHD | In distribution | |
| SOP35HSCGE | In distribution | |
| SOP18ASEFB | In distribution | |
| SOP38HPUL2 | In distribution | |
| PO33KNGNE | In distribution | |
| PO60LXCLJ | In distribution | |
| SOPHDAGSNA | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 53,097 |
| Avid TruCustom | Avid Medical, Inc. | 3,990 |
| ACS | American Contract Systems, Inc. | 3,812 |
| Halyard | Avid Medical, Inc. | 1,313 |
| Aligned Medical Solutions | Aligned Medical Solutions | 1,272 |
| Regard™ | ROi CPS LLC | 464 |
| Overwatch | Spinal Elements, Inc. | 223 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 191 |
| Lucent L | Spinal Elements, Inc. | 95 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 87 |
| Integra® | Ascension Orthopedics, Inc. | 81 |
| Sapphire | Spinal Elements, Inc. | 76 |
Showing 12 of 367. All products under Orthopedic Tray
Recalls Naming This Product
11 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 | 44 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. | 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 | 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 | 2023-08-16 | Class II | Material/Component Contamination | XXX | 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.