Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016980830

FEI Number

3016980830

Entity Name

PRAMAND LLC

City/State/Country

Bedford, MA, US

Establishment Address

201 Burlington Road, Suite 210, North Building, Bedford, MA 01730, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Pramand LLC (Owner Number: 10078839)

Owner / Operator Contact Address

201 Burlington Road, Suite 210, North Building, Bedford, MA 01730, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P240027

All Registered Proprietary Names

CraniSeal SpineSeal Spine Sealant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NQR	Sealant, Dural	Unknown	Class 3	N/A	2023-07-14
NQR	Sealant, Dural	Unknown	Class 3	N/A	2025-02-26

Official Correspondent

Sarah Fairfield

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pramand LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016980830. Last updated year: 2026. Please use registration number 3016980830 when referencing this establishment in official correspondence.