Cardinal Health
Laparoscopic Bariatric Pack
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Liaoning. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dalian Create Medical Products Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 2 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FDA |
| Device type | Enteroscope And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-09 |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 2, case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SBAHFLBMIA | In distribution | |
| SBA4JGLWLA | In distribution |
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| CD138 + Cyclin D1 | Biocare Medical, LLC | 1 |
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| Zeus-P | Spinal Elements, Inc. | 1 |
| Jade PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 1 |
| Premier Jackson Improved Short Tracheostomy Tube | Premier Dental Products Co. | 1 |
Showing 12 of 19. All products under Enteroscope And Accessories
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.