PROPLATE 9571C

GUDID 28809083941851

Electrosurgical Unit Ground Pad, Disposable, Single use, Neutral electrode, Non-corded, Horizontal, Solid, Adult, 180x120mm

BIOPROTECH INC.

Electrosurgical return electrode, single-use, non-sterile

• Primary Device ID: 28809083941851
• NIH Device Record Key: 49d83b0e-94eb-4bee-85a4-161a0d205924
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROPLATE
• Version Model Number: 9571C
• Catalog Number: 9571C
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809083941857 [Primary]
GS1	18809083941854 [Package]; Contains: 08809083941857; Package: Inner Box [20 Units]; In Commercial Distribution
GS1	28809083941851 [Package]; Contains: 18809083941854; Package: Carton Box [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073360

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: 2019-11-20
• Device Publish Date: 2019-11-12

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
• 18809083941090: ESU Grouding Plate, Vertical, Non-corded, Adult, Split, 105x215mm, Cloth