PKS Cutting Forceps 5mm/45cm

GUDID 00821925009530

Gyrus Acmi, Inc.

Endoscopic electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00821925009530
• NIH Device Record Key: a66faf3c-44b4-4361-8268-a6128dc9dd29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PKS Cutting Forceps 5mm/45cm
• Version Model Number: 3045PK
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, 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	00821925009530 [Package]; Contains: 00821925036031; Package: [5 Units]; In Commercial Distribution
GS1	00821925036031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023492

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: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-10-03

On-Brand Devices [PKS Cutting Forceps 5mm/45cm]

• 00821925009578: 920010PK
• 00821925009530: 3045PK