SureForm

Basic Information

• Brand Name: SureForm
• Primary DI: 00886874115640
• Version / Model: 480460
• Company Name: INTUITIVE SURGICAL, INC.
• Labeler DUNS: 938647021
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-10
• Public Version: 2
• Public Version Date: 2020-03-02
• Public Version Status: Update
• Public Device Record Key: 37ce7cdb-2064-4908-9256-461e64998442

Device Description

Stapler 60

Device Characteristics

• Single Use: Yes
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAY	System, surgical, computer controlled instrument	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58483	Endoscopic motorized cutting stapler, single-use	A sterile, hand-held, battery-powered surgical instrument designed to be used during endoscopic surgical procedures for the expeditious transection and resection of tissues and the creation of anastomoses; it may also be used during open surgery. The device is intended to mechanically cut the tissue and simultaneously apply surgical staples to the resulting sides of the cut line, with power from a motor in the handle. This device is typically loaded with staples and may be pistol-like in design. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10886874115647	GS1	BOX	6	In Commercial Distribution
Primary	00886874115640	GS1

Device Sizes

Type	Value	Unit	Text
Outer Diameter	14	Millimeter