Home GUDID 20860010683723 SpineSeal Spine Sealant
Primary DI 20860010683723
Brand SpineSeal Spine Sealant
Company Pramand LLC
Model SS-2055
Catalog number SS-2055
Device description The SpineSeal Spine Sealant is indicated as an adjuct to sutured dural repair during spine surgery to provide a watertight closure.
Published 2025-03-03
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NQR Sealant, Dural
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NQR Sealant, Dural Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860010683729 Primary GS1 0 20860010683723 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860010683729 00860010683729 860010683729 0860010683729 20860010683723 20860010683723
GMDN Terms# Term, Definition table Term Definition Dura mater sealant An implanted bioabsorbable material (e.g., solution, gel, spray, patch) intended to be applied to a defect in the dura mater, possibly as an adjunct to standard methods of closure (e.g., suturing), to prevent cerebrospinal fluid (CSF) leakage during healing. The material primarily consists of synthetic polymers that subsequently form adhesive bonds with the dura mater and eventually degrade and are absorbed. After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 0 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 117587283 Device count 5 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860010683705 CraniSeal Dural Sealant CS-2055 CS-2055 2023-08-15 00860010683729 SpineSeal Spine Sealant SS-2055 SS-2055 2025-03-03 00860010683712 CraniSeal Dural Sealant CS-2015 CS-2015 2023-08-15
Other Devices Sharing Product Codes#