Model: 20-0211-000
DI: M9432002110000
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Dilator 1
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
65ace840-8275-4d26-8d5d-4888d4e6b267
Distribution Status:
In Commercial Distribution
DUNS Number:
963359513
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
M9432002110000
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 37142
Name: Endoscopic-access dilator, reusable
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 reusable device.
FDA Product Codes
LXH
Orthopedic Manual Surgical Instrument