ERBE 20190-161

GUDID 28809083941707

2 button; holster; spatula electrode; L 3m

BIOPROTECH INC.

Electrosurgical handpiece, single-use

• Primary Device ID: 28809083941707
• NIH Device Record Key: b1f4c7db-9d5f-44f4-98d8-7792680fd3f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ERBE
• Version Model Number: 20190-161
• Catalog Number: 20190-161
• 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
• Storage Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809083941703 [Primary]
GS1	18809083941700 [Package]; Contains: 08809083941703; Package: Inner Box [25 Units]; In Commercial Distribution
GS1	28809083941707 [Package]; Contains: 18809083941700; Package: Carton Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092732

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: 2
• Public Version Date: 2023-04-04
• Device Publish Date: 2019-03-08

On-Brand Devices [ERBE]

• 28809083941783: rocker switch; spatula electrode; L 5 m
• 18809083941779: 2 button; spatula electrode; L 5m
• 28809083941769: rocker switch; holster; needle electrode; L 3m
• 28809083941752: rocker switch; needle electrode; L 3 m
• 28809083941745: 2 button; holster; needle electrode; L 3m
• 28809083941738: 2 button; needle electrode; L 3m
• 28809083941721: rocker switch; holster; spatula electrode; L 3m
• 28809083941707: 2 button; holster; spatula electrode; L 3m
• 28809083941691: 2 button; spatula electrode; L 3m
• 28809083941714: rocker switch; spatula electrode; L 3 m