Orfit Industries

GUDID 05420028725528

Orfit Industries NV

Pure-tone audiometer
Primary Device ID05420028725528
NIH Device Record Key3fe569d3-fa5d-48bc-9aa8-1fcfbbd53f25
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrfit Industries
Version Model Number60122
Company DUNS283679900
Company NameOrfit Industries NV
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Customer Support Contacts

Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com
Phone+3233262026
Emailwelcome@orfit.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105420028725528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, linear, medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-08

On-Brand Devices [Orfit Industries]

0542002879566860001/EFF2MA
0542002879404335776/24MA/NP
0542002878717535796/2MI
0542002878716835795/2MI
0542002878715135794/2MI
0542002878714435793/32MA
0542002878713735792/32MA
0542002878669760112/EFF2MI+
0542002878247760125
0542002878014560158
0542002877990360159
05420028777510Fraxion Head Mask (10 pcs.) Efficast 2 mm micro
0542002877686560164/5
0542002877521935791/2MA/NH/NP
0542002877258460119-UH
0542002877257760119-U
0542002877246160002/EFF32MA
0542002877147135776/2MI/MO
0542002877101335779/32MA
0542002876845735779/2MA/NH
0542002876803735779/2MA/G
0542002876695835775/2MI
0542002876462635776/2MI/NP
0542002876461935776/2MI
05420028763230Thermoplastic Mask Head ( 10 PCS) 10PC of 3 pt Hybrid Head Mask (P10106-300)
05420028763223Thermoplastic Mask Nose (10 PCS) P10106-301 10Pc of 3 pt HYBRID HEAD Nose Mask
0542002875564860097/EFF2MA
0542002875526635791/2MA/G17
0542002875516735779/16MI+N
0542002875504435791/16MI+N
0542002875487035774/16MI+N
0542002875330960124
0542002875327960114
0542002875155860002
0542002875133635773/2MI/E/NP
0542002875050660121
0542002875049060119
0542002874645535773/16MI/NH
05420028725771703011
0542002872555960123
0542002872552860122
0542002872548160120
0542002872545060117
0542002872541260112
0542002872538260110
0542002872533760097
0542002872531360095
0542002871832235791/2MI/NP
0542002871831535791/2MI
0542002871828535791/2MA/NH

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