L’DISQ®

GUDID 08800015911856

U&I CORPORATION

Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile Electrosurgical return electrode, single-use, sterile

• Primary Device ID: 08800015911856
• NIH Device Record Key: d817ab90-f8e5-4fc9-963c-5146065302c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L’DISQ®
• Version Model Number: PD07
• Company DUNS: 688811082
• Company Name: U&I CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800015911856 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132797

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-17
• Device Publish Date: 2016-09-24

On-Brand Devices [L’DISQ®]

• 08800015911856: PD07
• 08800015911849: PD05
• 08800015911832: PD04
• 08800015911825: PC02
• 08800015911818: PC01
• 08800015900027: PD03
• 08800015900010: PD01
• 08800015900003: PD02