FDA.reportPublic FDA data

PROBE 418 Master Probe

Primary DI
07332834000509
Brand
PROBE 418 Master Probe
Company
Perimed AB
Model
PROBE 418
Device description
PROBE 418 Master Probe
Published
2016-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935495000PF404/409/410/411/416/418 W/PF319:0/319:1/319:2Perimed, Inc.1994-04-18GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07332834000509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332834000509073328340005097332834000509

GMDN Terms#

Term, Definition table
TermDefinition
Laser Doppler blood flowmeterA mobile, mains electricity (AC-powered) device designed to use laser Doppler techniques to measure the velocity of micro- and macrovascular blood circulation to assess of the extent of vascular flow restrictions [e.g., clots, stenosis, mechanical damage, and peripheral vascular disease (PVD)]. It typically measures blood flow/perfusion, transcutaneous oxygen (TCOM) and/or carbon dioxide, and may have modules for heat provocation and pressure control. It typically consists of various laser Doppler probes, temperature measurement sensors, and pressure measuring cuff/sensors connected to a software-controlled control/visual display unit.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
354765570
Device count
1
Serial number
true

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07332834000240TC 550 Fixation Ring for tcpO2/CO2TC 5502017-02-14
07332834000257TC 555 Fixation Ring for tcpO2/CO2 - Extra Strength AdhesiveTC 5552017-02-14
07332834000264TC 560 Contact LiquidTC 5602016-09-13
07332834000271TC 550 TC 560 Fixation Ring and Contact Liquid for tcpO2/CO2 90-000422017-02-14
07332834000332PeriSoft for Windows Examination ManagerPSW ExM2016-09-13
07332834000349PeriSoft for Windows 2.5PSW 2.52016-09-13
07332834000400PF 5001 Main UnitPF 50012016-09-13
07332834000417PF 5002 Basic Main UnitPF 50022016-09-13
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07332834001117PF 6051 Pressure Accessory KitPF 605193-001862023-01-31
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07332834001131PF 6053 Segmental Pressure 4 Cuff Method KitPF 605393-002302023-01-31

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