Rectosigmoidoscope with Obturator

GUDID 05704916001360

Rectosigmoidoscope with obturator, compatible with Storz Light Source for 20R3 / 9052

Bk Medical ApS

Rigid endoscope obturator
Primary Device ID05704916001360
NIH Device Record Keya4eceec5-80a7-4454-9f10-51240bf64622
Commercial Distribution StatusIn Commercial Distribution
Brand NameRectosigmoidoscope with Obturator
Version Model NumberUA0673
Company DUNS310093901
Company NameBk Medical ApS
Device Count1
DM Exempttrue
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 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
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
GS105704916001360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-08
Device Publish Date2025-04-30

On-Brand Devices [Rectosigmoidoscope with Obturator]

05704916001360Rectosigmoidoscope with obturator, compatible with Storz Light Source for 20R3 / 9052
05704916001353Rectosigmoidoscope with obturator, compatible with Welch Allyn Light Source for 20R3 / 9052

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