FDA.reportPublic FDA data

MT B500-0L120 Straight Microtip

Primary DI
07332834000387
Brand
MT B500-0L120 Straight Microtip
Company
Perimed AB
Model
MT B500-0L120
Device description
MT B500-0L120 Straight Microtip
Published
2020-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
07332834000363PrimaryGS10
07332834000387Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07332834000363073328340003637332834000363
07332834000387073328340003877332834000387

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
354765570
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07332834000103PF 6001 Main UnitPF 60012016-09-13
07332834000127PF 6040 tcpO2/pCO2 UnitPF 60402016-09-13
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
07332834001162PF 6051-M Pressure Accessory Kit Metal BayonetPF 6051-M93-003252024-12-13
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07332834001131PF 6053 Segmental Pressure 4 Cuff Method KitPF 605393-002302023-01-31

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