Model: 81031R1FC
DI: 00037977810318
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
TEETHE & TAKE ALONG KEYS
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5eeeeec2-f38c-4218-8391-220dcf664b06
Distribution Status:
In Commercial Distribution
DUNS Number:
065061459
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
Device ID:
00037977810318
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44272
Name: Teething device, fluid-filled
Definition:
A circular or cylindrical device filled with fluid (e.g., water) intended to be bitten by a patient (infant or adult) to soothe gums during the teething process. This is a reusable device.
FDA Product Codes
KKO
Ring, Teething, Fluid-Filled