Model: 5254899
DI: 00850080491058
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-18
Description
Darby Frost Endo
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
4df8259d-8958-4606-aa68-457b4b13274c
Distribution Status:
In Commercial Distribution
DUNS Number:
121411859
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:
No
Identifiers
Item #1 - Device ID:
00850080491058
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10850080491055
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
12
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
00850080491058
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 38787
Name: Cryogenic spray, dental
Definition:
A liquid/gaseous refrigerant, typically contained in an aerosol or other spray dispenser, which is applied (sprayed) to a tooth to chill it, primarily to observe the patient's resulting intensity and duration of sensation in the evaluation of dental pulp vitality (i.e., helps to determine if the pulp is normal, inflamed, or necrotic). Some refrigerants may be used as a local anaesthetic when extracting deciduous teeth in children. After application, this device cannot be reused.
FDA Product Codes
EAT
Tester, Pulp