imbedbio.comMicrolyte Ag/Lidocaine
Imbed Biosciences
IMBED BIOSCIENCES INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013478891 | 3013478891 | IMBED BIOSCIENCES INC. | 1 | N | 2026-01-01 | 2241 Pinehurst Dr Middleton WI US 53562 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850019162325 | Surgaflex PainGuard - Surgaflex PainGuard, 2cm x 3cm | 888-472-9898 | cs@imbedbio.com |
| 00850019162332 | Surgaflex PainGuard - Surgaflex PainGuard, 4cm x 6cm | 888-472-9898 | cs@imbedbio.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 200697 | 1969337061 | K211943 | Microlyte Ag/Lidocaine | FRO | 2024-10-17 |
| 200697 | 1972385966 | K153756 | Microlyte Ag | FRO | 2016-08-04 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| FRO | 2 | 2024-10-17 |
PMN#
Microlyte Ag
IMBED BIOSCIENCES, INC.
GUDID#
Microlyte Matrix - Microlyte Matrix, 6 cm x 8 cm, Individually Packaged
2026-04-15
Microlyte PainGuard - Microlyte PainGuard, 3cm x 3cm
2025-08-21
Microlyte PainGuard - Microlyte PainGuard, 5cm x 5cm
2025-08-21
Microlyte PainGuard - Microlyte PainGuard, 10cm x 10cm
2025-08-21
Pelashield PainGuard - Pelashield PainGuard, 10cm x 23cm
2025-08-21
Pelashield PainGuard - Pelashield PainGuard, 15cm x 15cm
2025-08-21
Surgaflex PainGuard - Surgaflex PainGuard, 2cm x 3cm
2025-03-24
Surgaflex PainGuard - Surgaflex PainGuard, 4cm x 6cm
2025-03-24
Surgaflex PainGuard - Surgaflex PainGuard, 4cm x 10cm
2025-03-24
Surgaflex PainGuard - Surgaflex PainGuard, 4cm x 20cm
2025-03-24
Microlyte Matrix - Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2025-02-24
Surgaflex - Surgaflex, 4cm x 20cm, Individually packaged
2025-02-24
Surgaflex - Surgaflex, 4cm x 6cm, Individually Packaged
2025-02-24
Surgaflex - Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed box of 5.
2025-02-24
Surgaflex - Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sq in. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed boxes of 5.
2025-02-24
Microlyte Matrix - Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2025-02-24
Microlyte Matrix - Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2025-02-24
Microlyte Ag-Lidocaine Matrix - "Microlyte Ag-Lidocaine Matrix, 2"" x 2"", Individually packaged"
2025-01-21
Microlyte Ag-Lidocaine Matrix - "Microlyte Ag-Lidocaine Matrix, 4"" x 4"", Individually packaged"
2025-01-21
Microlyte Ag-Lidocaine Matrix - "Microlyte Ag-Lidocaine Matrix, 6"" x 6"", Individually packaged"
2025-01-21
Microlyte Matrix - "Microlyte Matrix, 6"" x 6"" (15 cm x 15 cm), Box of 5"
2024-07-31
Microlyte Matrix - "MicroLyte Matrix, 2"" x 9"" (5cm x 23 cm), Box of 5"
2024-07-31
Microlyte Matrix - "Microlyte Matrix, 4"" x 9"" (10 cm x 23 cm), Box of 5"
2024-07-31
Microlyte Ag VET - "Microlyte Ag VET Matrix, 2"" x 2"" (5 cm x 5 cm), Box of 5"
2024-07-31
Microlyte Ag VET - "Microlyte Ag VET Matrix, 4"" x 4"" (10 cm x 10 cm), Box of 5"
2024-07-31
Microlyte Matrix - Microlyte Matrix, 3 cm x 3 cm, Individually Packaged
2024-07-18
Microlyte Matrix - Microlyte Matrix, 4 cm x 4 cm, Individually Packaged
2024-07-18
PelashieldAM - PelashieldAM™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. PelashieldAM™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
Microlyte Matrix - Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
Microlyte Matrix - Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
Microlyte Matrix - Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
Microlyte Matrix - Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
Surgaflex - Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
Surgaflex - Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
Surgaflex - Surgaflex™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
Microlyte Matrix - Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
Microlyte Matrix - Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
Microlyte Matrix - Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
PelashieldAM - PelashieldAM™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. PelashieldAM™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02
PelashieldAM - PelashieldAM™ is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. PelashieldAM™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
2023-02-02