Model: BTCD13
DI: 00810212930442
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
BROOKS TYPE CORPORAL DILATOR #13
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:
c1664fbf-5981-42e5-b58a-d40bf3c2b77a
Distribution Status:
In Commercial Distribution
DUNS Number:
058689193
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
00810212930442
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 14286
Name: Urethral bougie, reusable
Definition:
A rod-like manual surgical instrument designed to explore the urethra and/or to dilate a urethral and/or urinary meatus stenosis. It is designed with a semi-rigid tapered shaft that terminates at the distal end in a small bulbous tip (an olive) and it typically has a handle at the proximal end. It may be hollow to enable passage of other slender devices. This is a reusable device.
FDA Product Codes
GCC
Dilator, Catheter