Surgicel
Absorbable Hemostat (oxidized regenerated cellulose, U.S.P.)
2manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Huan QIU LI Kang Biotech Co., Ltd. | Beijing | Beijing | Contract manufacturer | 2 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Ethicon Sàrl |
|---|---|
| FDA product code | LMG |
| Device type | Agent, Absorbable Hemostatic, Non-Collagen Based |
| Device class | Class 3 |
| Regulation | 21 CFR 878.4490 |
| 510(k) | N12159 |
| Record published | 2023-05-15 |
| Record revised | 2023-07-31 (version 12) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C; Storage environment temperature 59 to 86 °F |
| Packaging | Box of 12, case of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1951S | In distribution | |
| 1953S | In distribution | |
| 1952S | In distribution | |
| 1955 | In distribution | |
| 1953 | In distribution | |
| 1955S | In distribution | |
| 1952 | In distribution | |
| 1951 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgicel NU-Knit | Ethicon Sàrl | 6 |
| Surgicel SNoW | Ethicon, Inc. | 6 |
| Arista | Davol Inc. | 6 |
| Surgicel Fibrillar | Ethicon, Inc. | 5 |
| PerClot | Baxter Healthcare Corporation | 5 |
| Emergency Medical Products | Emergency Medical Products, Inc. | 3 |
| Veriset | Covidien LP | 3 |
| Surgicel Fibrillar | Ethicon Sàrl | 3 |
| Surgicel | Ethicon, Inc. | 1 |
| Tabotamp Fibrillar | Ethicon, Inc. | 1 |
| Ethicon | Ethicon, Inc. | 1 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P210036 | 2023-05-19 | PerClot® Polysaccharide Hemostatic System | Baxter Healthcare Corporation |
| N12159 | 2023-04-04 | SURGICEL® Absorbable Hemostats (SURGICEL® POWDER) | Ethicon, Inc. |
| P050038 | 2012-03-23 | ARISTA AH ABSORBABLE HEMOSTAT | Davol Inc. |
| N5798 | 1991-02-08 | OXYCELL | Bd Becton Dickinson Vacutainer Systems Preanalytic |
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.