MRI Needle Guide SNG

GUDID 04251135812105

MRI Needle Guide SNG for Soteria RCM Ø2,2x130mm

BIP Biomedizinische Instrumente und Produkte GmbH

Needle guide, single-use
Primary Device ID04251135812105
NIH Device Record Key4a4647b9-c2f1-40bc-b30d-ddcdcbb0003f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMRI Needle Guide SNG
Version Model NumberSNG18150
Company DUNS326467826
Company NameBIP Biomedizinische Instrumente und Produkte GmbH
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104251135812099 [Primary]
GS104251135812105 [Package]
Contains: 04251135812099
Package: [5 Units]
In Commercial Distribution

FDA Product Code

FZXGuide, Surgical, Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-04
Device Publish Date2023-06-26

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