Cardinal Health
Kit,general Bariatric Procedur
4manufacturers in China registered for this device type
9,245catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Anhui (2), Jiangsu (1), 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 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medical Sterilizing Co., Ltd. | Hefei | Anhui | Contract manufacturer | 8 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FDE |
| Device type | Laparoscopy Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-18 |
| 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 5, case of 6 |
| Distribution end date | 2017-10-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SBA30APPRA | In distribution | |
| SBACNGLRVA | In distribution | |
| SBA11LACPZ | In distribution | |
| PG40LCSLR | In distribution | |
| SMA2ALPSG4 | In distribution | |
| SBA29LPAMD | In distribution | |
| SBA69LSAS1 | In distribution | |
| SLC73BLSJ2 | In distribution | |
| PG29BTAG9 | In distribution | |
| SMA3BGUCLD | In distribution | |
| SLC26LPCCQ | In distribution | |
| SBA41GLTED | In distribution | |
| SBA21HGPM3 | In distribution | |
| SBA41LCNW3 | In distribution | |
| PG33LJO19 | In distribution | |
| SBA1DLCGNC | In distribution | |
| SBA19TLUWA | In distribution | |
| SMA43LSBRW | In distribution | |
| SBA21LGUH3 | In distribution | |
| PGOCLGJMO | In distribution | |
| SLCDHLCAPC | In distribution | |
| SBAW1LPSHA | In distribution | |
| SLC2DLCLV4 | In distribution | |
| SBA33LAOUE | In distribution | |
| PGHDLGV16 | In distribution | |
| SBA18GLGH6 | In distribution | |
| SBA69LPHD5 | In distribution | |
| SBA30PLPRB | In distribution | |
| SBA23GLWR2 | In distribution | |
| SBA38GLUL2 | In distribution | |
| SBA1DLCRH2 | In distribution | |
| SLCOCLCCS3 | In distribution | |
| PGVXGBLC9 | In distribution | |
| SBA43RLTSH | In distribution | |
| SBA48MSNMF | In distribution | |
| SLC11LH36G | In distribution | |
| SBA12LGAGS | In distribution | |
| SBA29GLFGU | In distribution | |
| SBA69GLK21 | In distribution | |
| SLC69LPHDF | In distribution | |
| SLC18SJNDP | In distribution | |
| SBA44GLSL3 | In distribution | |
| SLC53LPSSH | In distribution | |
| PG29GBP10 | In distribution | |
| SBA40BTB13 | In distribution | |
| SMA69GEBFJ | In distribution | |
| SBA13GSET1 | In distribution | |
| SBA57DLO21 | In distribution | |
| SMA33LGAH1 | In distribution | |
| PG24LCGMHP | In distribution | |
| SBA41GLTE1 | In distribution | |
| PG41LITHE | In distribution | |
| SLC30CHPR2 | In distribution | |
| SBACGLPME3 | In distribution | |
| PGHDLGVCB | In distribution | |
| PGOCLC36Q | In distribution | |
| PGVMGLBLT | In distribution | |
| SLC44LPMV4 | In distribution | |
| SBA69LGKW4 | In distribution | |
| SBA40LCBY3 | In distribution | |
| SBACNLPMF8 | In distribution | |
| SBA73LPKSE | In distribution | |
| SBA48MSNMD | In distribution | |
| PGV2LS01T | In distribution | |
| SMA2ALPSG2 | In distribution | |
| SBA33LAB13 | In distribution | |
| SBA12LPB12 | In distribution | |
| SLC41LPNU8 | In distribution | |
| SBACGLPACA | In distribution | |
| SBACGRPSH1 | In distribution | |
| SBACGRLOKC | In distribution | |
| SBA11BLHKO | In distribution | |
| SBA5BLCHEE | In distribution | |
| SLC51LC311 | In distribution | |
| SLC48LPHHA | In distribution | |
| SBA41LHBYE | In distribution | |
| SBA55PPKC2 | In distribution | |
| SBA33LAB24 | In distribution | |
| SBA40BRCFD | In distribution | |
| PG76LEHCQ | In distribution | |
| SBA11GRJM7 | In distribution | |
| SBA48LSLSB | In distribution | |
| SBA12HRNM4 | In distribution | |
| SBA23LSRC7 | In distribution | |
| SBA14LPCR4 | In distribution | |
| SBA3DGLMM3 | In distribution | |
| PGOCLSNS9 | In distribution | |
| SBA3ILPIPA | In distribution | |
| SBA13LSM15 | In distribution | |
| SBA31LC471 | In distribution | |
| SBA11LYENR | In distribution | |
| PG08GPGH3 | In distribution | |
| SBACGCLA10 | In distribution | |
| PG33BTO15 | In distribution | |
| SBA48LCLA1 | In distribution | |
| SLC73LCK14 | In distribution | |
| SBAHDLCUMA | In distribution | |
| SBA23LGHNA | In distribution | |
| SBA1DLCRHA | In distribution | |
| SBAOCGLNS3 | In distribution | |
| SBA11GL18A | In distribution | |
| SBA11LPHLI | In distribution | |
| SBA43LPSU2 | In distribution | |
| PG7CLCSRK | In distribution | |
| PBVZLSMFQ | In distribution | |
| SMA37LS308 | In distribution | |
| SBA40LPABC | In distribution | |
| PG30LPPR8 | In distribution | |
| SBA35LPTC5 | In distribution | |
| PGHDLGHU2 | In distribution | |
| SBA73LCKWA | In distribution | |
| SBA73GLWV2 | In distribution | |
| SBAOCGLCHK | In distribution | |
| SBA13GUMGG | In distribution | |
| SBA41GLBU1 | In distribution | |
| SBA41LCAM3 | In distribution | |
| SBA69GEBF1 | In distribution | |
| SBACNSUEH6 | In distribution | |
| SBAVXLCBMC | In distribution | |
| SBA43LSBRA | In distribution | |
| SBACGRLLGD | In distribution | |
| SBA41GLTE2 | In distribution | |
| SBA13GLSTD | In distribution | |
| SBA69LPKK4 | In distribution | |
| SBA21LPARA | In distribution | |
| SBA15LCUMG | In distribution | |
| SLC23L2525 | In distribution | |
| SMAOCLPHW4 | In distribution | |
| SBA73GLJCG | In distribution | |
| SBA19RPUW3 | In distribution | |
| SBACGLCSHF | In distribution | |
| SLC5FLCABB | In distribution | |
| SBA69LSASD | In distribution | |
| SBA69LSASE | In distribution | |
| SLCOCLYSF3 | In distribution | |
| SBA45LAASB | In distribution | |
| SLC54LCTM1 | In distribution | |
| SBA15LCUM1 | In distribution | |
| SLC41LCNW1 | In distribution | |
| PB55BPC11 | In distribution | |
| SBA69BRSU5 | In distribution | |
| PGOCLPBDD | In distribution | |
| SBA22GLWRB | In distribution | |
| SLC08LCOHB | In distribution | |
| PG55LC316 | In distribution | |
| SBAV2LBPVB | In distribution | |
| SBA53GLKGE | In distribution | |
| SBA11GLJOZ | In distribution | |
| SBAHDLGMJP | In distribution | |
| SBA33LCSEB | In distribution | |
| PGVNLG554 | In distribution | |
| SBA22LAMS3 | In distribution | |
| PGOCGLNH1 | In distribution | |
| PG30LPP29 | In distribution | |
| SLC69LGFRB | In distribution | |
| SBA22LAMS2 | In distribution | |
| SMA31LPSJH | In distribution | |
| SLC73MLVDC | In distribution | |
| SBAHDLPAAF | In distribution | |
| PG29BTAGB | In distribution | |
| SBAVXLCWH3 | In distribution | |
| SBA3DLPMML | In distribution | |
| SBA23LAHM7 | In distribution | |
| SMA36LB87J | In distribution | |
| SBA45GLSUF | In distribution | |
| PG08GPGHQ | In distribution | |
| SBA51LC31B | In distribution | |
| SBA53LCV15 | In distribution | |
| SBA69GLKPC | In distribution | |
| SBA11LPRTA | In distribution | |
| SBACGCLAUC | In distribution | |
| PG3BLPUS9 | In distribution | |
| SBAMILPSID | In distribution | |
| SBA24LPBCE | In distribution | |
| SLC45LACCK | In distribution | |
| SBA21GLBR1 | In distribution | |
| SBA59LASFG | In distribution | |
| SMA19LPSVO | In distribution | |
| SBACGRLOK2 | In distribution | |
| PG30LPP14 | In distribution | |
| SBA12GLKPJ | In distribution | |
| PG40RBSL3 | In distribution | |
| SBA23LAHMH | In distribution | |
| SBA15LCU10 | In distribution | |
| SBA44LPPSA | In distribution | |
| SBA69GLK11 | In distribution | |
| PGOCGS36I | In distribution | |
| SLC37LPSJA | In distribution | |
| SLC29LPRM2 | In distribution | |
| PGOCGLNH3 | In distribution | |
| SBA21LAH16 | In distribution | |
| SBA73LCKHA | In distribution | |
| PBV2LSNYV | In distribution | |
| PGOCGS36J | In distribution | |
| PG40LCKG5 | In distribution | |
| SBAOCLCEHL | In distribution | |
| SLC73LCSJ1 | In distribution | |
| SBAOCGLME3 | In distribution | |
| SBA40LCBHA | In distribution | |
| SBA69GEBFA | In distribution | |
| SBA58LSGSA | In distribution | |
| SBA35LAPLA | In distribution | |
| SLC21LCMC3 | In distribution | |
| SBA11GRJM5 | In distribution | |
| PGDHRSPCD | In distribution | |
| SBA13LSMR2 | In distribution | |
| SBA63LHSEE | In distribution | |
| SBACGLCSHC | In distribution | |
| SBA12GLHFD | In distribution | |
| SBACGGLM14 | In distribution | |
| SBA41LCNOX | In distribution | |
| SBA12LPBBM | In distribution | |
| SBA73LPKM4 | In distribution | |
| SBA44LSSLD | In distribution | |
| PGHDLGHUD | In distribution | |
| SBA57GBKPN | In distribution | |
| SBA7ALCPN1 | In distribution | |
| SBAHBLCTS1 | In distribution | |
| SBA76LCHCC | In distribution | |
| SLC53LCISE | In distribution | |
| SBAW1RGMHA | In distribution | |
| SBADKGLFL2 | In distribution | |
| SBA73GLRSF | In distribution | |
| PG29LCPCU | In distribution | |
| SMA73LSC20 | In distribution | |
| SBA53LCVSB | In distribution | |
| SMA69GEBFG | In distribution | |
| SBA73LPCHB | In distribution | |
| SBAHDLPKP7 | In distribution | |
| SBA11LCHTD | In distribution | |
| SBA53LCSP1 | In distribution | |
| SLC18CJNDT | In distribution | |
| SBA7ALCXX6 | In distribution | |
| SMA82LS171 | In distribution | |
| END488341D | In distribution | |
| SLC53LCAGD | In distribution | |
| SBA48LCPD2 | In distribution | |
| SBAOCGLNH2 | In distribution | |
| PG4ELAHTA | In distribution | |
| SBA21HGPM6 | In distribution | |
| PG54LAGRT | In distribution | |
| SBADHGL77C | In distribution | |
| PG30LPPRB | In distribution | |
| SBA53LPEOA | In distribution | |
| PG24LCNO1 | In distribution | |
| SBA18GLNDA | In distribution | |
| PG29LCP11 | In distribution | |
| PGOCLC15D | In distribution | |
| SBAOCGUP10 | In distribution | |
| PGVXGBL23 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 23,145 |
| ACS | American Contract Systems, Inc. | 988 |
| Aligned Medical Solutions | Aligned Medical Solutions | 156 |
| DeRoyal | Deroyal Industries, Inc. | 141 |
| Regard™ | ROi CPS LLC | 122 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 61 |
| Medline | Medline Industries, Inc. | 19 |
| Halyard | Avid Medical, Inc. | 13 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 9 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
Showing 12 of 17. All products under Laparoscopy Kit
Recalls Naming This Product
2 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 | 36 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.