3D X-Ray Pattern Phantom ROSAS00299

GUDID 03760244032263

"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"

MEDTECH

Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system Multi-purpose stereotactic surgery system
Primary Device ID03760244032263
NIH Device Record Key704b9136-36db-4e54-a087-c4b1a7ed247f
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D X-Ray Pattern Phantom
Version Model Number224173-00
Catalog NumberROSAS00299
Company DUNS264502977
Company NameMEDTECH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]
GS103760244032263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


[03760244032263]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-07-31
Device Publish Date2020-06-02

On-Brand Devices [3D X-Ray Pattern Phantom]

037602440306273D X-RAY PATTERN PHANTOM instrument Rosa one (spine application) Mock-up of the 3D X-ray pattern
03760244032263"3D X-RAY PATTERN PHANTOM instrument Rosa one 3.1 (spine application) Mock-up of the 3D X-ray pa

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.