Model: SFSSAMT10209-01_0001
Catalog: SFSSAMT10209-01
DI: 10809160520642
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ef799b97-c5a7-4517-b971-ff0888a34993
Distribution Status:
In Commercial Distribution
DUNS Number:
015623119
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
10809160520642
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46416
Name: Urological surgical procedure kit, medicated, single-use
Definition:
A collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological surgical procedure. This is a single-use device.
FDA Product Codes
LRO
General surgery tray