PMI LAPSYSTEM™ LSDLS-33CVMETZ

GUDID 00850013527786

PMI LAPSYSTEM™ Disposable Monopolar 5mm x 33cm Scissor, Fully Insulated

Dannik LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00850013527786
• NIH Device Record Key: 307e748b-e707-4bff-bfff-85b6b1b89fb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMI LAPSYSTEM™
• Version Model Number: LSDLS-33CVMETZ
• Catalog Number: LSDLS-33CVMETZ
• Company DUNS: 117407001
• Company Name: Dannik LLC
• Device Count: 10
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013527786 [Unit of Use]
GS1	10850013527783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193019

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2024-06-07
• Device Publish Date: 2024-05-30

Devices Manufactured by Dannik LLC

• 00850013527038 - Dannik: 2024-08-07 Disposable Monopolar 5mm x 33cm Scissor, Fully Insulated
• 00850013527045 - Dannik: 2024-08-07 Disposable Monopolar 5mm x 33cm Autraumatic Fenestrated Grasper, Ratcheting
• 00850013527052 - Dannik: 2024-08-07 Disposable Monopolar 5mm x 33cm Maxi Grip Fenestrated Grasper, Ratcheting
• 00850013527069 - Dannik: 2024-08-07 Disposable Monopolar 5mm x 33cm Curved Maryland Dissector, Ratcheting
• 00850013527342 - Dannik: 2024-08-07 Disposable Monopolar 5mm x 33cm Babcock Grasper, Ratcheting
• 00850013527359 - Dannik: 2024-08-07 Disposable Monopolar 5mm x 33cm Curved Maryland Dissector, Non-Ratcheting
• 00850013527786 - PMI LAPSYSTEM™: 2024-06-07PMI LAPSYSTEM™ Disposable Monopolar 5mm x 33cm Scissor, Fully Insulated
• 00850013527786 - PMI LAPSYSTEM™: 2024-06-07 PMI LAPSYSTEM™ Disposable Monopolar 5mm x 33cm Scissor, Fully Insulated
• 00850013527502 - EXTEND: 2024-02-23 Extend 10mm Specimen Retrieval System, 240mL