PROPLATE 9572C

GUDID 18809083942882

Electrosurgical Unit Grounding Pad, Return, Uncorded, Disposable

BIOPROTECH INC.

Electrosurgical return electrode, single-use

• Primary Device ID: 18809083942882
• NIH Device Record Key: 63fe0483-bd91-44b5-ba41-51457941651e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROPLATE
• Version Model Number: 9572C
• Catalog Number: 9572C
• Company DUNS: 688460539
• Company Name: BIOPROTECH INC.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809083942885 [Primary]
GS1	18809083942882 [Package]; Contains: 08809083942885; Package: Inner Box [20 Units]; In Commercial Distribution
GS1	28809083942889 [Package]; Package: Carton Box [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092761

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-26
• Device Publish Date: 2021-04-16

On-Brand Devices [PROPLATE]

• 28809083941851: Electrosurgical Unit Ground Pad, Disposable, Single use, Neutral electrode, Non-corded, Horizont
• 18809083942882: Electrosurgical Unit Grounding Pad, Return, Uncorded, Disposable
• 18809083944794: Disposable Solid Adult ESU Grouding Pad with Cable