SurroundScope Endoscope 300004

GUDID 07290116580005

SurroundScope Endoscope 90 deg

270 SURGICAL LTD

Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope Rigid video laparoscope

• Primary Device ID: 07290116580005
• NIH Device Record Key: 4ed67d15-dc6d-4a3a-b592-e33a5a990135
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurroundScope Endoscope
• Version Model Number: SurroundScope Endoscope
• Catalog Number: 300004
• Company DUNS: 531854929
• Company Name: 270 SURGICAL LTD
• 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: false
• Serial Number: true
• 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: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com
• Phone: 1 610-613-5570
• Email: info@270surgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290116580005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210104

FDA Product Code

• HET: Laparoscope, Gynecologic (And Accessories)

Sterilization

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

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

[07290116580005]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-03
• Device Publish Date: 2021-11-25

Devices Manufactured by 270 SURGICAL LTD

• 07290116580005 - SurroundScope Endoscope: 2021-12-03SurroundScope Endoscope 90 deg
• 07290116580005 - SurroundScope Endoscope: 2021-12-03 SurroundScope Endoscope 90 deg
• 07290116582009 - SurroundScope CCU: 2021-12-03 Camera Control Unit for SurroundScope
• 07290116583006 - SurroundScope Sterilization Tray: 2021-12-03 Sterilization Tray for SurroundScope