SurroundScope Endoscope

Basic Information

• Brand Name: SurroundScope Endoscope
• Primary DI: 07290116580005
• Version / Model: SurroundScope Endoscope
• Catalog Number: 300004
• Company Name: 270 SURGICAL LTD
• Labeler DUNS: 531854929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-25
• Public Version: 1
• Public Version Date: 2021-12-03
• Public Version Status: New
• Public Device Record Key: 4ed67d15-dc6d-4a3a-b592-e33a5a990135

Device Description

SurroundScope Endoscope 90 deg

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43053	Rigid video laparoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the organs/structures of the abdominal/retroperitoneal cavity. It is inserted through a dedicated incision made in the abdominal wall during laparoscopy. Images are transmitted by a camera/video system to a monitor for viewing by the user. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290116580005	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K210104	000