Cardinal Health
EENT Split Sheet, Absorbent reinforcement, adhesive, Nonsterile
5manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Guangxi (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Hebei Ruinuo Medical Instrument Co Ltd | Shijiazhuang | Hebei | Manufacturer | 29 |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
| Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. | Siyang | Jiangsu | Manufacturer | 21 |
| Jiangsu Hanheng Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 20 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | ERY |
| Device type | Drape, Surgical, Ent |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-08 |
| Record revised | 2022-06-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 5, case of 48, case of 15 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SBA38HHSFA | In distribution | ||
| SBA11JUMDA | In distribution | ||
| 9442NA | 540 | In distribution | |
| SBA11JUMDB | In distribution | ||
| 9442ANA | 540 | In distribution | |
| SBA18DPFHA | In distribution | ||
| SNE38HDSVA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Convertors | Cardinal Health 200, LLC | 46 |
| Hepro.us Surgical/Examination Suit M | Hepro.us Inc. | 1 |
| Hepro.us Welcome Pack – Case | Hepro.us Inc. | 1 |
| Isolaer Aerosol Isolation Barrier | Inquis Medical, Inc. | 1 |
| Hepro.us General Pack 1 Pouch | Hepro.us Inc. | 1 |
| Hepro.us Surgical Scrub Suit 50pcs per Case | Hepro.us Inc. | 1 |
| Hepro.us Welcome Pack | Hepro.us Inc. | 1 |
| Hepro. US General Pack – 10 Pouches-Case | Hepro.us Inc. | 1 |
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.