Model: AV16S-13
Catalog: AV16S-13
DI: 00860014559211
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-01
Current Version: 2026-05-11
Description
Aventus Introducer Sheath - 16Fr x 13 cm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
bb4e1b8b-7f01-40f4-998b-3ad5b35881a2
Distribution Status:
In Commercial Distribution
DUNS Number:
117606791
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
00860014559211
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58865
Name: Vascular catheter introduction set, nonimplantable
Definition:
A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
FDA Product Codes
DYB
Introducer, Catheter
Premarket Submissions
Submission Number:
K260091
Supplement Number:
000