SpineSeal Spine Sealant SS-2055

GUDID 20860010683723

The SpineSeal Spine Sealant is indicated as an adjuct to sutured dural repair during spine surgery to provide a watertight closure.

Pramand LLC

Dura mater sealant

• Primary Device ID: 20860010683723
• NIH Device Record Key: 15f5ff41-28fc-4adc-8bee-c2407bc0bcd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpineSeal Spine Sealant
• Version Model Number: SS-2055
• Catalog Number: SS-2055
• Company DUNS: 117587283
• Company Name: Pramand LLC
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010683729 [Primary]
GS1	20860010683723 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240027

FDA Product Code

• NQR: Sealant, Dural

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-11
• Device Publish Date: 2025-03-03

Devices Manufactured by Pramand LLC

• 20860010683723 - SpineSeal Spine Sealant: 2025-03-11The SpineSeal Spine Sealant is indicated as an adjuct to sutured dural repair during spine surgery to provide a watertight closure.
• 20860010683723 - SpineSeal Spine Sealant: 2025-03-11 The SpineSeal Spine Sealant is indicated as an adjuct to sutured dural repair during spine surgery to provide a watertight closu
• 00860010683712 - CraniSeal Dural Sealant: 2023-08-23 The CraniSeal Dural Sealant is indicated for use in patients greater than or equal to 18 years of age as an adjunct to sutured d