Model: 4325
DI: 00616784432526
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3fd86a53-e1da-4bf1-a527-367555e48bb5
Distribution Status:
In Commercial Distribution
DUNS Number:
008124539
Device Count:
1000
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:
Yes
Identifiers
Item #1 - Device ID:
00810180845182
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00616784432526
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Case
Item #3 - Device ID:
00616784432533
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
10
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00616784432526
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 42461
Name: Tongue depressor, examination, single-use
Definition:
A hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device.
FDA Product Codes
HNB
Spoon, Ophthalmic