Fischer Cone Biopsy Excisor

GUDID 20888937003745

Fischer Cone Biopsy Excisor; Large Shallow

Coopersurgical, Inc.

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: 20888937003745
• NIH Device Record Key: 1a43220e-c42b-4a8b-bce6-d361839b86c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fischer Cone Biopsy Excisor
• Version Model Number: 900-155
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937003741 [Primary]
GS1	20888937003745 [Package]; Contains: 00888937003741; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061651

FDA Product Code

• HGI: Electrocautery, Gynecologic (And 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: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-08-16

On-Brand Devices [Fischer Cone Biopsy Excisor]

• 20888937003776: Fischer Cone Biopsy Excisor; Small Wide Angle Extended
• 20888937003769: Fischer Cone Biopsy Excisor; Small Wide Angle
• 20888937003745: Fischer Cone Biopsy Excisor; Large Shallow
• 20888937003738: Fischer Cone Biopsy Excisor; Medium Extended
• 20888937003721: Fischer Cone Biopsy Excisor; Large
• 20888937003714: Fischer Cone Biopsy Excisor; Medium
• 20888937003707: Fischer Cone Biopsy Excisor; Small