Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027383505

FEI Number

3027383505

Entity Name

TYBR HEALTH, INC.

City/State/Country

Houston, TX, US

Establishment Address

2450 Holcombe Blvd Ste X, Houston, TX 77021, US

Establishment Type(s)

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

Owner / Operator

TYBR Health, Inc. (Owner Number: 10093752)

Owner / Operator Contact Address

2450 Holcombe Blvd, Suite X, Houston, TX 77021, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250109

PMA Number

N/A

All Registered Proprietary Names

B3 GEL System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon	General, Plastic Surgery	Class 2	878.3300	2025-07-02
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2025-07-02

Official Correspondent

Timothy Keane

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TYBR Health, 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
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

Similar Registrations

Registration Number	Establishment Name	Location
3005381997	LifeNet Health	Virginia Bch, VA, US
1320894	CONMED CORPORATION	Utica, NY, US
3010155661	Synergy Health Sterilisation UK Ltd	Thorne Doncaster, GB
3012448339	STERI-TEK	Fremont, CA, US
1047843	ISOMEDIX OPERATIONS INC.	SPARTANBURG, SC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027383505. Last updated year: 2026. Please use registration number 3027383505 when referencing this establishment in official correspondence.