FDA.reportPublic FDA data

Verify

Primary DI
M7403150006
Brand
Verify
Company
SPINEOLOGY INC.
Model
10-01-80
Catalog number
315-0006
Device description
Verify™ Cannula & Bladder
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBACatheter, Balloon Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBACatheter, Balloon TypeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7403150006PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Catheter/overtube balloon inflator, single-useA device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
651-256-8500info@spineology.com

Regulatory Flags#

DUNS number
033014361
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7403150031OptiMesh Multiplanar Expandable Interbody Fusion System10-10-110315-00312026-03-20
M7409200001OptiMesh Multiplanar Expandable Interbody Fusion System92-01-01920-00012026-03-12
M7402700021Rampart-O83-05-04270-00212024-06-03
M7401001350Rampart One Lumbar Interbody Fusion System102-76-01100-13502026-01-29
M7401001360Elite Expandable Interbody Fusion System102-83-01-01100-13602026-01-28
M7401001361Elite Expandable Interbody Fusion System102-83-01-02100-13612026-01-28
M7401001362Elite Expandable Interbody Fusion System102-83-01-03100-13622026-01-28
M7401001363Elite Expandable Interbody Fusion System102-83-01-04100-13632026-01-28
M7401001364Elite Expandable Interbody Fusion System102-83-01-05100-13642026-01-28
M7401001365Elite Expandable Interbody Fusion System102-83-01-06100-13652026-01-28
M7401001366Elite Expandable Interbody Fusion System102-83-01-07100-13662026-01-28
M7401001367Elite Expandable Interbody Fusion System102-83-01-08100-13672026-01-28
M7401001368Elite Expandable Interbody Fusion System102-83-01-09100-13682026-01-28
M7401001369Elite Expandable Interbody Fusion System102-83-01-10100-13692026-01-28
M7401000279SOAR Retractor System100-19-17100-02792026-01-20
M7405002628OptiMesh HA Nano Multiplanar Expandable Interbody Fusion System32-01-37-4500-26282025-12-19
M7405003032OptiMesh HA Nano Multiplanar Expandable Interbody Fusion System32-01-37-2500-30322025-12-19
M7405003440OptiMesh HA Nano Multiplanar Expandable Interbody Fusion System32-01-37-3500-34402025-12-19
M7401610041OptiMesh Navigation Instruments16-13-08161-00412025-12-17
M7401610050OptiMesh Navigation Instruments16-09-07161-00502025-12-17

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