Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027588012

FEI Number

3027588012

Entity Name

TYRO MEDICAL, LLC

City/State/Country

Ridgefield, CT, US

Establishment Address

14 Rochambeau Avenue, Ridgefield, CT 06877, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Tyro Medical, LLC (Owner Number: 10088272)

Owner / Operator Contact Address

14 Rochambeau Avenue, Ridgefield, CT 06877, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tyro C-Arm Drape PC3-VB10-RC PC3-SCSA-3 Dynamis Surgical Arm Drape PC3-VB10-E Dynamis Scout Arm Drape PC3-VB10-SC Dynamis Cart Drape PC2-SD-3 Dynamis Control Screen Drape KK70L150S KK100L50S BC4508S KK45R50S KK70L50S BC4508U KK100L150S BC7008U KK45R150S BC7008S KK100L21S KK70L21S KK45R21S BC1001U BC1001S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2023-06-29
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2025-07-31

Official Correspondent

david rothkopf

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tyro Medical, 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 3027588012. Last updated year: 2026. Please use registration number 3027588012 when referencing this establishment in official correspondence.