FDA UDI In Commercial Distribution 🇺🇸 United States

3D X-Ray Pattern Phantom

DI: 03760244032263 · Model: 224173-00 · MEDTECH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
3D X-Ray Pattern Phantom
Primary DI
03760244032263
Version / Model
224173-00
Catalog Number
ROSAS00299
Company Name
MEDTECH
Labeler DUNS
264502977
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-02
Public Version
5
Public Version Date
2024-01-08
Public Version Status
Update
Public Device Record Key
704b9136-36db-4e54-a087-c4b1a7ed247f

Device Description

"3D X-RAY PATTERN PHANTOM instrument Rosa one 3.1 (spine application) Mock-up of the 3D X-ray pattern to adjust intraoperative imaging system"

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
MR Unsafe
Direct Marking Exempt
No
PM Exempt
No
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
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
OLO Orthopedic Stereotaxic Instrument

GMDN Terms

Code Name
45199 Multi-purpose stereotactic surgery system

Identifiers

Type ID
Primary 03760244032263