FDA UDI Not in Commercial Distribution 🇺🇸 United States

EndoVue

DI: 00818089021966 · Model: 90K0083 · Nds Surgical Imaging LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
EndoVue
Primary DI
00818089021966
Version / Model
90K0083
Company Name
Nds Surgical Imaging LLC
Labeler DUNS
081712583
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-06-24
Public Version
2
Public Version Date
2022-10-24
Public Version Status
Update
Public Device Record Key
e8e297cf-4c02-4d47-bb60-655014d5ec9b
Distribution End Date
2022-06-27

Device Description

ENDOVUE, 32", CHINA, BC-WU32-N1418

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KQM Camera, Surgical And Accessories

GMDN Terms

Code Name
36612 Image display unit, colour

Identifiers

Type ID
Primary 00818089021966