TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET
SURGICAL APPLIANCE INDUSTRIES, INC.
SURGICAL APPLIANCE INDUSTRIES, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1511629 | 1511629 | SURGICAL APPLIANCE INDUSTRIES, INC. | 1 | N | 2026-01-01 | 3960 ROSSLYN DR. CINCINNATI OH US 45209 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 31765 | 1340934712 | K192234 | ActiPatch | PQY | 2020-01-31 |
| 31765 | 1253463504 | K121106 | TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET | DWL | 2012-04-27 |
| 31765 | 1030645501 | ||||
| 31765 | 1058291650 | ||||
| 31765 | 1073964703 | ||||
| 31765 | 1173255960 | ||||
| 31765 | 1277199992 | ||||
| 31765 | 1279593023 | ||||
| 31765 | 1313080519 | ||||
| 31765 | 1360267118 | ||||
| 31765 | 1391923866 | ||||
| 31765 | 1393778557 | ||||
| 31765 | 1538153349 | ||||
| 31765 | 1558097602 | ||||
| 31765 | 1563115697 | ||||
| 31765 | 1602771629 | ||||
| 31765 | 1636489096 | ||||
| 31765 | 1644812519 | ||||
| 31765 | 1655579767 | ||||
| 31765 | 1658844048 | ||||
| 31765 | 1682939487 | ||||
| 31765 | 1689108732 | ||||
| 31765 | 1737117900 | ||||
| 31765 | 1776350544 | ||||
| 31765 | 1787305864 | ||||
| 31765 | 1820089042 | ||||
| 31765 | 1862665884 | ||||
| 31765 | 1885688406 | ||||
| 31765 | 1894465237 | ||||
| 31765 | 2021424432 | ||||
| 31765 | 2063553512 |
Product Codes Associated With Registrations#
PMN#
TRUNCAL ORTHOSIS
SURGICAL APPLIANCE INDUSTRIES, INC.
EXTERNAL BREAST PROSTHESIS
SURGICAL APPLIANCE INDUSTRIES, INC.
NEOPRENE KNEE SUPPORT
SURGICAL APPLIANCE INDUSTRIES, INC.
CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS
SURGICAL APPLIANCE INDUSTRIES, INC.
CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O
SURGICAL APPLIANCE INDUSTRIES, INC.
CYLINDER KNEE CAST/SPLINT
SURGICAL APPLIANCE INDUSTRIES, INC.
ANKLE-FOOT CAST/SPLINT
SURGICAL APPLIANCE INDUSTRIES, INC.
LUMBO-SACRAL FLEXION ORTHOSIS
SURGICAL APPLIANCE INDUSTRIES, INC.
GUDID#
Truform® - 0878BG-S
2024-12-05
Truform® - 0878BG-M
2024-12-05
Truform® - 0878BG-L
2024-12-05
Truform® - 0878BG-XL
2024-12-05
Truform® - 0878BG-2L
2024-12-05
Truform® - 31773ND-XL
2024-12-05
Truform® - 0868BG-2L
2020-03-04
Truform® - 1772LB-2L
2020-03-04
Truform® - 1772LB-3L
2020-03-04
Truform® - 1773LB-2L
2020-03-04
Truform® - 1773LB-3L
2020-03-04
Truform® - 1772BG-2L
2020-03-04
Truform® - 1772BG-3L
2020-03-04
Truform® - 1772BL-2L
2020-03-04
Truform® - 1772BL-3L
2020-03-04
Truform® - 0868BL-2L
2020-03-04
Truform® - 1772TP-2L
2020-03-04
Truform® - 1772TP-3L
2020-03-04
Truform® - 1773TP-2L
2020-03-04
Truform® - 1773TP-3L
2020-03-04
Truform® - 0865GR-S
2020-03-04
Truform® - 0865GR-M
2020-03-04
Truform® - 0865GR-L
2020-03-04
Truform® - 0865GR-XL
2020-03-04
Truform® - 0865GR-2L
2020-03-04
Truform® - 0865GR-3L
2020-03-04
Truform® - 0263WH-S
2020-03-04
Truform® - 0263WH-M
2020-03-04
Truform® - 0263WH-L
2020-03-04
Truform® - 0263WH-XL
2020-03-04
Truform® - 1772WH-2L
2020-03-04
Truform® - 1772WH-3L
2020-03-04
Truform® - 1773WH-2L
2020-03-04
Truform® - 1773WH-3L
2020-03-04
Truform® - 1772CH-S
2020-03-04
Truform® - 1772CH-M
2020-03-04
Truform® - 1772CH-L
2020-03-04
Truform® - 1772CH-XL
2020-03-04
Truform® - 1772CH-2L
2020-03-04
Truform® - 1772CH-3L
2020-03-04