Carilex VT¿200-i NX
Carilex Medical, Inc.
Carilex Medical, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9710603 | 3003513125 | Carilex Medical, Inc. | 1 | N | 2026-01-01 | No. 77, Keji 1st Rd. Guishan District Taoyuan TW 333 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 59791 | 1157593015 | K231646 | Carilex VT¿200-i NX | OMP | 2024-04-17 |
| 59791 | 1730340840 | K202823 | Innomed NPWT Silicone Foam Dressing | OMP | 2021-12-15 |
| 59791 | 1201779515 | K173407 | VT - 100, VT - 200 | OMP | 2018-08-09 |
| 59791 | 1317225805 | K172725 | VT Dressing Kits | OMP | 2018-06-08 |
| 59791 | 1666135660 | K161410 | VT·One, VT·One 60days | OMP | 2016-10-13 |
| 59791 | 1569803776 | K112853 | VOLTERA POWERED SUCTION PUMP | OMP | 2012-11-09 |
| 59791 | 1025655807 | ||||
| 59791 | 1022119972 | ||||
| 59791 | 1094390458 | ||||
| 59791 | 1156935209 | ||||
| 59791 | 1199365102 | ||||
| 59791 | 1212682013 | ||||
| 59791 | 1358395259 | ||||
| 59791 | 1512554469 | ||||
| 59791 | 1679004734 | ||||
| 59791 | 1793651384 | ||||
| 59791 | 1911377235 | ||||
| 59791 | 1938122312 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OMP | 6 | 2024-04-17 |
PMN#
VT - 100, VT - 200
Carilex Medical, Inc.
VT Dressing Kits
Carilex Medical, Inc.
VT·One, VT·One 60days
CARILEX MEDICAL, INC.
GUDID#
NA - Silicone Foam Dressing 10 x 20cm
2026-08-26
NA - Silicone Foam Dressing 10 x 30cm
2026-08-26
NA - Silicone Foam Dressing 10 x 40cm
2026-08-26
NA - Silicone Foam Dressing 15 x 15cm
2026-08-26
NA - Silicone Foam Dressing 15 x 20cm
2026-08-26
NA - Silicone Net 5 x 7.5cm
2026-08-26
NA - Silicone Net 7.5 x 10cm
2026-08-26
NA - Silicone Net 10 x 10cm
2026-08-26
NA - Silicone Net 10 x 18cm
2026-08-26
NA - Silicone Net 15 x 20cm
2026-08-26
NA - Silicone Net 20 x 30cm
2026-08-26
NA - "Envelop Cover 42"" x 80"" VTX Carilex-1p"
2025-12-22
NA - "Envelop Cover 48"" x 80"" VTX Carilex-1p"
2025-12-22
NA - "Envelop M-set 42"" x 80"" VTX Carilex"
2025-12-22
NA - "Envelop M-set 48"" x 80"" VTX Carilex"
2025-12-22
NA - Envelop Cover 42" x 80" VTX Carilex-1p
2025-12-22
NA - Envelop Cover 48" x 80" VTX Carilex-1p
2025-12-22
NA - VT Dressing Kit M Carilex
2018-12-05
NA - VT Dressing Kit L Carilex
2018-11-28
NA - VT Spiral Dressing Kit Black Lock
2021-03-16
NA - VT Drape and Port Set Kit S Lock
2018-06-12
NA - VT Drape and Port Set Kit M Lock
2018-06-12
NA - VT Drape and Port Set Kit L Lock
2018-06-12
NA - VT Dressing Kit Black Foam-M
2018-06-12
NA - VT Dressing Kit Black Foam-L
2018-06-12
NA - VT Port Set Kit
2021-03-16
NA - VT•100 Y-Connector
2021-03-16
NA - VT Dressing Kit XL Carilex
2018-12-05
NA - VT Dressing Kit NX S Carilex
2020-12-18
NA - VT Dressing Kit NX M Carilex
2020-12-14
NA - VT Dressing Kit NX L Carilex
2020-12-18
NA - VT Dressing Kit NX XL Carilex
2020-12-18
NA - VT Dressing Universal Adaptor
2021-03-16
NA - VT Dressing Kit TS S Carilex
2020-03-24
NA - VT Dressing Kit TS M Carilex
2020-03-24
NA - VT Dressing Kit TS L Carilex
2020-03-24
NA - VT Drape 2pcs pack
2021-03-16
NA - VT Drape and Port Set Kit S Lock
2018-06-12
NA - VT Drape and Port Set Kit M Lock
2018-06-12
NA - VT Drape and Port Set Kit L Lock
2018-06-12