FDA.reportPublic FDA data

Envision

Primary DI
00860014541704
Brand
Envision
Company
SPINAL STABILIZATION TECHNOLOGIES LIMITED
Model
9015
Catalog number
9015
Device description
Envision Balloon Catheter, Super Soft
Published
2026-04-30
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
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
00860014541704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860014541704008600145417048600145417040860014541704

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.

Contacts#

Phone, Email table
PhoneEmail
+1 800 484 1588clinical@sstspine.com

Regulatory Flags#

DUNS number
985617309
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860014541711Envision901690162026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014541711EnvisionSPINAL STABILIZATION TECHNOLOGIES LIMITEDGBA2026-04-30
06979032640031GOBENHUZHOU JUNDA INDUSTRY CO., LTD.GBA2025-08-26
M7403150006VerifySPINEOLOGY INC.GBA2023-06-26
00887482173718Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.GBA2022-09-21
00678467004963 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005007 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005847 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005915 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006134 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006547 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006677 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006707 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006868 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506184 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506252 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506276 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506337 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506610 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467001450Mui ScientificH & A Mui Enterprises IncGBA2019-10-16
00678467001627 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467001894 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467001924 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002150 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002358 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002426 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002549 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002600 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002655 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467003058 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467003065 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16