Device
Envision Balloon Catheter, Soft
Manufacturer
SPINAL STABILIZATION TECHNOLOGIES LIMITED
SPINAL STABILIZATION TECHNOLOGIES LIMITED
Model: 9016
Catalog: 9016
DI: 00860014541711
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Envision Balloon Catheter, Soft
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
1e6792f9-933e-4fd4-960c-659d41271ef2
Distribution Status:
In Commercial Distribution
DUNS Number:
985617309
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860014541711
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 17541
Name: Catheter/overtube balloon inflator, single-use
Definition:
A 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.
FDA Product Codes
GBA
Catheter, Balloon Type