SureForm

GUDID 10886874117580

SureForm 45

INTUITIVE SURGICAL, INC.

Robotic surgical cutting stapler, single-use Robotic surgical cutting stapler, single-use

• Primary Device ID: 10886874117580
• NIH Device Record Key: 084a4ab9-722f-4252-9b99-ef4007b62cb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureForm
• Version Model Number: 480445
• Company DUNS: 938647021
• Company Name: INTUITIVE SURGICAL, INC.
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 14 Millimeter
• Outer Diameter: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886874117583 [Primary]
GS1	10886874117580 [Package]; Contains: 00886874117583; Package: BOX [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183224

FDA Product Code

• GDW: Staple, implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-02
• Device Publish Date: 2019-03-15

On-Brand Devices [SureForm]

• 10886874117580: SureForm 45
• 10886874117122: SUREFORM 45 RELOAD WHITE
• 10886874117115: SUREFORM 45 RELOAD BLACK
• 10886874117092: SUREFORM 45 RELOAD GREEN
• 10886874117085: SUREFORM 45 RELOAD BLUE
• 10886874115647: Stapler 60
• 10886874113858: STAPLER 60 RELOAD BLACK
• 10886874113841: STAPLER 60 RELOAD GREEN
• 10886874113834: STAPLER 60 RELOAD BLUE
• 10886874113827: STAPLER 60 RELOAD WHITE
• 10886874117597: SureForm 45 Curved-Tip
• 10886874117108: SUREFORM 45 RELOAD GRAY
• 10886874121938: 8mm Stapler
• 10886874121921: 8mm Stapler
• 10886874121914: 8mm Stapler
• 10886874121723: 8mm Stapler