Knot guide

GUDID 04059082015415

SOPRO-COMEG GmbH

Endoscopic suturing unit, reusable

• Primary Device ID: 04059082015415
• NIH Device Record Key: 57f6fc6d-f55a-41ac-ad5e-d2bafdcadc3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Knot guide
• Version Model Number: 392 999 403
• Company DUNS: 507185952
• Company Name: SOPRO-COMEG GmbH
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04059082015415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945266

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

[04059082015415]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [Knot guide]

• 04059082015439: 392 999 453
• 04059082015422: 392 999 450
• 04059082015415: 392 999 403
• 04059082015392: 392 999 401
• 04059082015385: 392 999 400