Model: N6-D5/1
DI: 00846338001353
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
16G x 5" Needle
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
78527f30-413d-4e04-946b-d567f2cb0b90
Distribution Status:
In Commercial Distribution
DUNS Number:
019872358
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:
00846338001353
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 38821
Name: Endoscopic-access dilator, single-use
Definition:
A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.
FDA Product Codes
GDF
Guide, Needle, Surgical