MR Stylet

GUDID 57340007000480

Clinical Laserthermia Systems AB

Catheter stylet Catheter stylet
Primary Device ID57340007000480
NIH Device Record Key3372b3fe-977e-4dde-950e-f67365850eeb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMR Stylet
Version Model Number4013-06
Company DUNS774856749
Company NameClinical Laserthermia Systems AB
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS117340007000482 [Primary]
GS137340007000486 [Package]
Contains: 17340007000482
Package: [5 Units]
In Commercial Distribution
GS157340007000480 [Package]
Contains: 17340007000482
Package: [10 Units]
In Commercial Distribution

FDA Product Code

GAHStylet, Surgical, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-06

On-Brand Devices [MR Stylet]

573400070004804013-06
373400070006084013-13
373400070005854013-11
373400070005614013-08

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