FDA UDI In Commercial Distribution 🇺🇸 United States

Allura Xper FD

DI: 00884838059092 · Model: Allura Xper FD10/10 OR Table · Philips Medical Systems Nederland B.V.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Allura Xper FD
Primary DI
00884838059092
Version / Model
Allura Xper FD10/10 OR Table
Catalog Number
722024
Company Name
Philips Medical Systems Nederland B.V.
Labeler DUNS
413819707
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
7
Public Version Date
2023-09-26
Public Version Status
Update
Public Device Record Key
36588a5b-ee15-45ef-ae2f-9bb54b421104

Device Description

Biplane Interventional X-Ray System with floor-mounted frontal stand (10-inch flat detector), ceiling-mounted lateral stand ( 10-inch flat detector) and interface for an OR table.

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
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
OWB Interventional Fluoroscopic X-Ray System
IZI System, X-Ray, Angiographic

GMDN Terms

Code Name
37623 Stationary angiographic x-ray system, digital

Identifiers

Type ID
Primary 00884838059092