Model: 1000435
DI: 00813502013009
Status: Update
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-01-12
Current Version: 2026-05-22
Description
14Fr Low Profile Introducer, 1UP, long (25cm)
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
d53d42a1-6123-490c-ac8b-b799c023b4ff
Distribution Status:
In Commercial Distribution
DUNS Number:
050636737
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00813502013009
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