MAST BIOSURGERY USA INC.

FDA Device Registration & Listing · SAN DIEGO, CA, US · Registration 3004661493

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004661493
FEI Number
3004661493
Entity Name
MAST BIOSURGERY USA INC.
City/State/Country
SAN DIEGO, CA, US
Establishment Address
6749 Top Gun St Ste 108, SAN DIEGO, CA 92121, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Mast Biosurgery USA (Owner Number: 9064241)
Owner / Operator Contact Address
6749 Top Gun St., Suite 108, San Diego, CA 92121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

OrthoWrap SURGIWRAP SurgiWrap FROST SurgiWrap Adhesion Barrier Film SurgiWrap FROST Adhesion Barrier Film CardioWrap Adhesion Barrier Film OrthoWrap Adhesion Barrier Film

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2008-11-04
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2006-07-25
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2021-08-13
MCN Barrier, Absorbable, Adhesion Unknown Class 3 N/A 2023-05-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mast Biosurgery USA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K220540 Covidien ProGrip Self-Gripping Polypropylene Mesh 2022-09-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004661493. Last updated year: 2026. Please use registration number 3004661493 when referencing this establishment in official correspondence.
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