Cardinal Health
General Purpose Instrument SET
1manufacturer
11catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | PXV |
| Device type | General Purpose Instrument Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-09 |
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 |
| Storage | Storage environment temperature up to 40 °C |
| Packaging | Case of 2, case of 10, case of 21, case of 30, case of 51, case of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07-0116I | In distribution | |
| SBA4JLPUNB | In distribution | |
| 07-4502A | In distribution | |
| SNU35ISCR1 | In distribution | |
| 07-3938F | In distribution | |
| SER33IAAHB | In distribution | |
| 07-4040A | In distribution | |
| SBA4JLPUNC | In distribution | |
| 07-7233C | In distribution | |
| 07-0116G | In distribution | |
| SBA4JLPUNA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MCI – Medical Concept Innovation, Inc. | MCI Medical Concept Innovation Inc. | 14 |
| Cygnus | Cygnus Medical L.L.C. | 9 |
| BR Surgical, LLC | BR Surgical LLC | 8 |
| Headless Screw System Instruments | Tyber Medical | 4 |
| Tyber Medical | Tyber Medical | 3 |
| Stradis Healthcare | Stradis Healthcare | 2 |
| Centurion | Centurion Medical Products Corporation | 2 |
| Oasis Biodegradable Scope Transport Tray with Reversible lid | Cygnus Medical L.L.C. | 2 |
| SingleCycle Disposable Instrument Tray | Cygnus Medical L.L.C. | 2 |
| Bundle – SingleCycle Disposable Instrument Tray and “biohazard/Soiled I | Cygnus Medical L.L.C. | 2 |
| OsteoCentric Trauma Small Frag Plate Surgical Case | OsteoCentric Technologies,Inc | 1 |
| SingleCycle Biohazard Self-Sealing label 25″ | Cygnus Medical L.L.C. | 1 |
Showing 12 of 46. All products under General Purpose Instrument Tray
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.