Model: 1
Catalog: 590
DI: 00851232007905
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2019-05-01
Current Version: 2026-05-21
Distribution End: 2026-04-03
Description
Single Use Semi-rigid Intubating Stylet.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
6
Record Key:
c1f14397-d517-4f11-8bca-a7aaef275c15
Distribution Status:
Not in Commercial Distribution
DUNS Number:
080384219
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
00851232007905
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
CASE
Item #2 - Device ID:
20851232007077
Item #2 - Pkg Status:
Not in Commercial Distribution
Item #2 - Pkg Quantity:
10
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00851232007905
Item #2 - Pkg Discontinue Date:
2026-04-03
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 37469
Name: Artificial airway stylet, single-use
Definition:
A long stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a single-use device.
FDA Product Codes
BSR
Stylet, Tracheal Tube