Model: OTT-16
DI: 00810055255115
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-17
Current Version: 2026-05-25
Description
Color-Coded Tuning Fork Set with Hammer
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5cbfe732-ed2d-4ab8-b9d4-a992c00ad3dc
Distribution Status:
In Commercial Distribution
DUNS Number:
112617522
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:
00810055255115
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62526
Name: Urostomy bag/support kit
Definition:
A collection of devices intended to be used for attachment/replacement of a urostomy bag (for collecting urine following a urostomy procedure). It includes not only the urostomy bag and base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device.
FDA Product Codes
GWX
Fork, Tuning