FDA UDI Not in Commercial Distribution 🇺🇸 United States

uREzpocus

DI: 00866955000485 · Model: uREzpocus C · Norland at Swissray
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
uREzpocus
Primary DI
00866955000485
Version / Model
uREzpocus C
Company Name
Norland at Swissray
Labeler DUNS
110329096
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-03-15
Public Version
2
Public Version Date
2026-01-27
Public Version Status
Update
Public Device Record Key
1dc55a45-61cd-4e6c-842b-162061034d59
Distribution End Date
2021-12-31

Device Description

Convex probe.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IYN System, Imaging, Pulsed Doppler, Ultrasonic

GMDN Terms

Code Name
40761 General-purpose ultrasound imaging system

Identifiers

Type ID
Primary 00866955000485