PKS SEAL Open Forceps Curved Jaw

GUDID 00821925010574

Gyrus Acmi, Inc.

Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

• Primary Device ID: 00821925010574
• NIH Device Record Key: 51cc7e24-b8f2-45b4-9a5a-8b98838e94e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PKS SEAL Open Forceps Curved Jaw
• Version Model Number: 3103PK
• 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	00821925010574 [Package]; Contains: 00821925036048; Package: [5 Units]; In Commercial Distribution
GS1	00821925036048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024286

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-11

On-Brand Devices [PKS SEAL Open Forceps Curved Jaw]

• 00821925009448: 915000PK
• 00821925010574: 3103PK