StitchKit

GUDID 00860004977339

StitchKit® PR Suture and Needle Management Device

ORIGAMI SURGICAL LLC

Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial

• Primary Device ID: 00860004977339
• NIH Device Record Key: 8ba7098a-8004-4ebd-b363-d3ce24ce1f7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StitchKit
• Version Model Number: SK-105
• 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
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com
• Phone: 9737656256
• Email: info@origamisurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004977339 [Primary]
GS1	10860004977336 [Package]; Package: Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211792

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-05
• Device Publish Date: 2023-03-28

On-Brand Devices [StitchKit]

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• 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