FDA UDI In Commercial Distribution 🇺🇸 United States

Invivo

DI: 00884838091818 · Model: 459801572611 · Philips DS North America LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Invivo
Primary DI
00884838091818
Version / Model
459801572611
Company Name
Philips DS North America LLC
Labeler DUNS
118983916
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-01-22
Public Version
4
Public Version Date
2023-08-10
Public Version Status
Update
Public Device Record Key
f89df81e-a40a-4252-92f7-849d5cad9f9e

Device Description

UroNav Version 3

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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LLZ System, image processing, radiological

GMDN Terms

Code Name
40873 Ultrasound imaging system application software

Identifiers

Type ID
Primary 00884838091818

Customer Contacts