StitchKit

GUDID 00860088000206

StitchKit ePTFE Suture Delivery Canister

ORIGAMI SURGICAL LLC

Polytetrafluoroethylene suture

• Primary Device ID: 00860088000206
• NIH Device Record Key: 4e2efc2a-6c51-4629-8754-39115cca344f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StitchKit
• Version Model Number: SK-002
• Company DUNS: 079994267
• Company Name: ORIGAMI SURGICAL LLC
• 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

Customer Support Contacts

• Phone: 9737656256
• Email: info@origamisurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860088000206 [Primary]
GS1	00860088000213 [Package]; Package: Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123811

FDA Product Code

• NAY: System,Surgical,Computer Controlled Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-26

On-Brand Devices [StitchKit]

• 00860088000206: StitchKit ePTFE Suture Delivery Canister
• 00860088000237: StitchKit® PTFE Suture and Needle Management Device
• 00860004977353: StitchKit® RHP Suture and Needle Management Device
• 00860004977346: StitchKit® RSCP Suture and Needle Management Device
• 00860004977339: StitchKit® PR Suture and Needle Management Device
• 10860004977312: StitchKit® HE Suture and Needle Management Device
• 10860004977305: StitchKit® BA Suture and Needle Management Device
• 10860004977381: StitchKit® URO Suture and Needle Management Device
• 10860004977374: StitchKit® RNY Suture and Needle Management Device
• 00860004977322: StitchKit® EC Suture and Needle Management Device