Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013012623

FEI Number

3013012623

Entity Name

Viscus Biologics, LLC.

City/State/Country

Cleveland, OH, US

Establishment Address

26309 Miles Road, Suite 1, Cleveland, OH 44128, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Viscus Biologics LLC (Owner Number: 10052742)

Owner / Operator Contact Address

26309 Miles Road, Suite 1, Cleveland, OH 44128, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190155

PMA Number

N/A

All Registered Proprietary Names

Radiopaque Tissue Marker FibermarX Radiopaque Tissue Marker BaseMEM FibermarX VeraForm Adaptable Tissue Marker

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEU	Marker, Radiographic, Implantable	General, Plastic Surgery	Class 2	878.4300	2017-06-29
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-06-20
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2016-09-26
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2019-03-19

Official Correspondent

Donna Campbell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Viscus Biologics LLC

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
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.

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3015924373	AUSA Medical Device Pvt Ltd	Bangalore Karnataka, IN
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013012623. Last updated year: 2026. Please use registration number 3013012623 when referencing this establishment in official correspondence.