Rob12C4

GUDID 05704916001599

The Rob12C4 drop-in transducer enables unique access to complex organs and difficult-to-access anatomy during robotic-assisted procedures.

Bk Medical ApS

Surgical ultrasound imaging transducer
Primary Device ID05704916001599
NIH Device Record Key1f536cec-ecc0-46f1-8099-857254dab99e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRob12C4
Version Model Number9096
Company DUNS310093901
Company NameBk Medical ApS
Device Count1
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailsupport@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com
Phone+4544528100
Emailinfo@bkmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105704916001599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Chlorine Dioxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

[05704916001599]

Hydrogen Peroxide;Peracetic Acid

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-31
Device Publish Date2022-05-23

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