PMI LAPSYSTEM™ LSDLS-33BBCK

GUDID 00850013527441

PMI LAPSYSTEM™ Disposable Laparoscopic Grasper, 33cm Shaft with Babcock Grasper Tip, Monopolar, Ratcheting

Dannik LLC

Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00850013527441
• NIH Device Record Key: de914ff5-8e96-414c-afc4-55baf13875ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMI LAPSYSTEM™
• Version Model Number: LSDLS-33BBCK
• Catalog Number: LSDLS-33BBCK
• 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	00850013527441 [Unit of Use]
GS1	10850013527448 [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: 2024-10-31
• Device Publish Date: 2024-10-23

On-Brand Devices [PMI LAPSYSTEM™]

• 00850013527786: PMI LAPSYSTEM™ Disposable Monopolar 5mm x 33cm Scissor, Fully Insulated
• 00850013527809: PMI LAPSYSTEM™ Disposable Laparoscopic Grasper, 33cm Shaft with Atraumatic Fenestrated Grasper
• 00850013527441: PMI LAPSYSTEM™ Disposable Laparoscopic Grasper, 33cm Shaft with Babcock Grasper Tip, Monopolar
• 00850013527410: PMI LAPSYSTEM™ Disposable Laparoscopic Dissector, 33cm Shaft with Curved Maryland Dissector Ti
• 00850013527397: PMI LAPSYSTEM™ Disposable Laparoscopic Scissor, 33cm Shaft with Curved Mini-Metz Scissor Tip,