MT B500-0L120 Straight Microtip

GUDID 07332834000387

MT B500-0L120 Straight Microtip

Perimed AB

Laser Doppler blood flowmeter
Primary Device ID07332834000387
NIH Device Record Key2d80c34a-1a19-4df5-a88a-8a5e56052a0a
Commercial Distribution StatusIn Commercial Distribution
Brand NameMT B500-0L120 Straight Microtip
Version Model NumberMT B500-0L120
Company DUNS354765570
Company NamePerimed AB
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107332834000363 [Primary]
GS107332834000387 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-23
Device Publish Date2020-04-15

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