Model: SENOCDOUC7
Catalog: SENOCDOUC7
DI: 10198956476073
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
Description
DENTAL OP PACK
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
70970155-ceba-4d41-b6d4-17dcf00be994
Distribution Status:
In Commercial Distribution
DUNS Number:
961027315
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
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:
Yes
Identifiers
Item #1 - Pkg Type:
CASE
Item #1 - Device ID:
50198956476071
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
3
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10198956476073
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10198956476073
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 45148
Name: Dental/maxillofacial surgical procedure kit, non-medicated, single-use
Definition:
A collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.
FDA Product Codes
OFX
General purpose dental tray