Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016504086

FEI Number

3016504086

Entity Name

GEL4MED, INC.

City/State/Country

Lowell, MA, US

Establishment Address

110 Canal St, 2nd floor, Lowell, MA 01852, US

Establishment Type(s)

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

Owner / Operator

Gel4Med, INC. (Owner Number: 10089559)

Owner / Operator Contact Address

1660 Soldiers Field Rd, STE 7, Brighton, MA 02135, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222025

PMA Number

N/A

All Registered Proprietary Names

G4Derm / G4Derm Plus Synthetic Wound Matrix G4Derm Plus RV-X1 Suprello

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gel4Med, INC.

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

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

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3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016504086. Last updated year: 2026. Please use registration number 3016504086 when referencing this establishment in official correspondence.