CraniSeal Dural Sealant - The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure.
2023-08-15
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016980830 | 3016980830 | PRAMAND LLC | 1 | N | 2026-01-01 | 201 Burlington Road Suite 210, North Building Bedford MA US 01730 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860010683705 | CraniSeal Dural Sealant - The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure. | 781-222-0081 | regulatory@pramandllc.com |
| 00860010683712 | CraniSeal Dural Sealant - The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured dural repair during cranial surgery to provide a watertight closure. | 781-222-0081 | regulatory@pramandllc.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 313182 | 1743366195 | P240027 | SpineSeal Spine Sealant | NQR | 2025-02-14 |
| 313182 | 1343807732 | P220014 | CraniSeal Dural Sealant | NQR | 2023-07-06 |
2023-08-15
2025-03-03
2025-03-03
2023-08-15