Model: 5Z989MD
DI: 00840161307132
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b7d6f55e-041f-4cde-82c1-cbee3af96f61
Distribution Status:
In Commercial Distribution
DUNS Number:
064783913
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
00840161307132
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
80840161307138
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
50
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00840161307132
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00840161311979
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
100
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00840161307132
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 37434
Name: Dental suction system cannula, single-use
Definition:
A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.
FDA Product Codes
DYN
Mouthpiece, Saliva Ejector