Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2437459

FEI Number

3000718659

Entity Name

DIRECTMED, INC.

City/State/Country

GLEN COVE, NY, US

Establishment Address

98 PRATT OVAL, GLEN COVE, NY 11542, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

DIRECTMED, INC. (Owner Number: 9030198)

Owner / Operator Contact Address

98 PRATT OVAL, --, Glen Cove, NY 11542, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Grace Medical, Inc. OTOMED, Inc.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2022-03-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DIRECTMED, INC.

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

View Entity Profile →

Similar Registrations

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3017435705	CENTESE, INC.	Omaha, NE, US
1057421	GRACE MEDICAL, INC.	Memphis, TN, US
2521402	B. BRAUN MEDICAL INC.	BETHLEHEM, PA, US
2246552	Isomedix Operations Inc.	S Plainfield, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2437459. Last updated year: 2026. Please use registration number 2437459 when referencing this establishment in official correspondence.