xx.xxREVOLVE ENVI 600 Advanced Adipose System
LifeCell Corporation
LifeCell Corporation
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008307571 | 3008307571 | LifeCell Corporation | 1 | N | 2020-04-25 | 220 Evans Way Branchburg NJ US 08876 |
| 3009586277 | 3009586277 | LifeCell Corporation | 1 | N | 2020-04-25 | 95 Corporate Dr Bridgewater NJ US 08807 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M32802040040 | Conexa Reconstructive Tissue Matrix - Conexa 2cm x 4cm Thin Firm Product, Tendon | 800-367-5737 | xx@xx.xx |
| M32803030030 | Conexa Reconstructive Tissue Matrix - Conexa 3cm x 3cm Thick Pliable Product, Rotator Cuff | 800-367-5737 | xx@xx.xx |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 208411 | 1563046382 | K163647 | Revolve Envi 600 Advanced Adipose System | MUU | 2017-08-25 |
| 208412 | 1563046382 | K163647 | Revolve Envi 600 Advanced Adipose System | MUU | 2017-08-25 |
| 208412 | 1363938590 | K162752 | ARTIA Reconstructive Tissue Matrix Perforated | FTM | 2017-02-24 |
| 208411 | 1363938590 | K162752 | ARTIA Reconstructive Tissue Matrix Perforated | FTM | 2017-02-24 |
| 208411 | 1795014723 | K150712 | LTM-Perforated Surgical Mesh | FTM | 2015-07-02 |
| 208412 | 1795014723 | K150712 | LTM-Perforated Surgical Mesh | FTM | 2015-07-02 |
| 208411 | 1987176599 | K142326 | HP Tissue Matrix | FTM | 2014-12-23 |
| 208412 | 1987176599 | K142326 | HP Tissue Matrix | FTM | 2014-12-23 |
| 208411 | 2049051054 | K130817 | LTN - LAPAROSCOPIC SURGICAL MESH | OXK | 2013-04-17 |
| 208412 | 2049051054 | K130817 | LTN - LAPAROSCOPIC SURGICAL MESH | OXK | 2013-04-17 |
| 208412 | 1002606824 | K120902 | GID 700 | MUU | 2012-08-15 |
| 208411 | 1002606824 | K120902 | GID 700 | MUU | 2012-08-15 |
| 208411 | 1160324222 | K082176 | LTM-BPS SURGICAL MESH | FTM | 2008-11-14 |
| 208412 | 1160324222 | K082176 | LTM-BPS SURGICAL MESH | FTM | 2008-11-14 |
| 208411 | 1916353224 | K070560 | LRTM SURGICAL MESH | FTM | 2007-06-11 |
| 208412 | 1916353224 | K070560 | LRTM SURGICAL MESH | FTM | 2007-06-11 |
| 208411 | 1218928444 |
Product Codes Associated With Registrations#
PMN#
Revolve Envi 600 Advanced Adipose System
LifeCell Corporation
ARTIA Reconstructive Tissue Matrix Perforated
LIFECELL CORPORATION
LTM-Perforated Surgical Mesh
LifeCell Corporation
HP Tissue Matrix
LifeCell Corporation
GUDID#
Conexa Reconstructive Tissue Matrix - Conexa 2cm x 4cm Thin Firm Product, Tendon
2015-09-17
Conexa Reconstructive Tissue Matrix - Conexa 3cm x 3cm Thick Pliable Product, Rotator Cuff
2015-09-17
Conexa Reconstructive Tissue Matrix - Conexa 4cm x 4cm Thin Firm Product, Tendon
2015-09-17
Conexa Reconstructive Tissue Matrix - Conexa 5cm x 5cm Thick Pliable Product, Rotator Cuff
2015-09-17
Conexa Reconstructive Tissue Matrix - Conexa 5cm x 10cm Thick Pliable Product, Rotator Cuff
2015-09-17
Conexa Reconstructive Tissue Matrix - Conexa 5cm x 10cm Thin Firm Product, Tendon
2015-09-17
Conexa Reconstructive Tissue Matrix - Conexa 6cm x 6cm Thin Firm Product, Tendon
2015-09-17
Strattice Reconstructive Tissue Matrix BPS - BPS Strattice 3 cm x 14 cm - Pliable
2015-09-17
Strattice Reconstructive Tissue Matrix BPS - BPS Strattice 4 cm x 16 cm - Pliable
2015-09-17
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 5 x 16, Pliable
2015-09-17
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 6 x 6, Firm
2015-09-17
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 6cm x 8cm, Pliable
2015-09-17
Strattice Reconstructive Tissue Matrix Laparoscopic - Strattice Laparoscopic 6cm x 8cm
2015-09-17
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 06 x 10, Firm
2015-09-17
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 06 x 13, Pliable
2015-09-17
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 6 x 16, Firm
2015-09-17
ARTIA Reconstructive Tissue Matrix - ARTIA Reconstructive Tissue Matrix 6 cm x 16 cm
2016-10-28
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 8 x 8, Firm
2015-09-17
Strattice Reconstructive Tissue Matrix BPS - BPS Strattice 8 cm x 8 cm - Pliable
2015-09-17
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 08 x 15, Pliable
2015-09-17
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 8 x 16, Pliable
2015-09-17
ARTIA Reconstructive Tissue Matrix - ARTIA Reconstructive Tissue Matrix 8 cm x 16 cm
2016-10-28
ARTIA Reconstructive Tissue Matrix - ARTIA Reconstructive Tissue Matrix 8 cm x 20 cm
2016-10-05
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 10 x 10, Firm
2015-09-17
Strattice Reconstructive Tissue Matrix Laparoscopic - Strattice Laparoscopic 10cm x 10cm
2015-09-17
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 10 x 16, Firm
2015-09-17
Strattice Reconstructive Tissue Matrix Extra Thick - Strattice Reconstructive Tissue Matrix Extra Thick, 10 x 16 rectangle
2016-12-05
Strattice Reconstructive Tissue Matrix Perforated - Strattice Reconstructive Tissue Matrix Perforated 10 x 16 cm rectangle
2015-11-13
Strattice Reconstructive Tissue Matrix Laparoscopic - Strattice Laparoscopic 10cm x 16cm
2015-09-17
Strattice Reconstructive Tissue Matrix BPS - BPS Strattice 10 cm x 16 cm - Pliable
2015-09-17
ARTIA Reconstructive Tissue Matrix - ARTIA Reconstructive Tissue Matrix 10 cm x 16 cm
2016-10-28
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 10 x 20, Firm
2015-09-17
Strattice Reconstructive Tissue Matrix Perforated - Strattice Reconstructive Tissue Matrix Perforated 10 x 20 cm rectangle
2016-10-06
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 10 x 25, Firm
2015-09-17
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 15 x 25, Firm
2015-09-17
Strattice Reconstructive Tissue Matrix Extra Thick - Strattice Reconstructive Tissue Matrix Extra Thick, 15 x 25 rectangle
2016-12-05
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 15 x 30, Firm
2015-09-17
Strattice Reconstructive Tissue Matrix Extra Thick - Strattice Reconstructive Tissue Matrix Extra Thick, 15 x 35 rectangle
2016-12-05
Strattice Reconstructive Tissue Matrix Perforated - Strattice Reconstructive Tissue Matrix Perforated 15 x 35 cm rectangle
2016-10-06
Strattice Reconstructive Tissue Matrix - Strattice Reconstructive Tissue Matrix, 16 x 20, Firm
2015-09-17