Rectosigmoidoscope with Obturator

GUDID 05704916001353

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

Bk Medical ApS

Rigid endoscope obturator

• Primary Device ID: 05704916001353
• NIH Device Record Key: 616b2a4c-8d0d-44bb-a61f-427bdbdbf258
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rectosigmoidoscope with Obturator
• Version Model Number: UA0672
• Company DUNS: 310093901
• Company Name: Bk Medical ApS
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com
• Phone: +4544528100
• Email: info@bkmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05704916001353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173569

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-08
• Device Publish Date: 2025-04-30

On-Brand Devices [Rectosigmoidoscope with Obturator]

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