FDA.reportPublic FDA data

B3 GEL System

Primary DI
00860011716730
Brand
B3 GEL System
Company
Tybr Health, Inc.
Model
B3TNP04061
Device description
B3 GEL System - 4 mL / 6 cm
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTMMesh, Surgical
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTMMesh, SurgicalGeneral, Plastic Surgery2
OWYMesh, Surgical, Collagen, Orthopaedics, Reinforcement Of TendonGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250109000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250109000TYBR Collagen GelTybr Health2025-06-06OWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011716730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011716730008600117167308600117167300860011716730

GMDN Terms#

Term, Definition table
TermDefinition
Tendon spacerAn implantable device intended to be used to physically isolate a tendon so that it can function without adhering to adjacent tissue.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-385-3218support@tybrhealth.com

Regulatory Flags#

DUNS number
117403452
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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