SHAVER BLADE BIPOLAR, SERRATED DIEGO ELITE

GUDID 00821925028029

Gyrus Acmi, Inc.

Metal/carbide ENT bur, single-use

• Primary Device ID: 00821925028029
• NIH Device Record Key: ade150d8-6393-43f4-addb-3e2cf62db5ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHAVER BLADE BIPOLAR, SERRATED DIEGO ELITE
• Version Model Number: BB4000SS
• 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	00821925028029 [Package]; Contains: 00821925038134; Package: [5 Units]; In Commercial Distribution
GS1	00821925038134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123429

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: 2016-10-13

On-Brand Devices [SHAVER BLADE BIPOLAR, SERRATED DIEGO ELITE]

• 00821925028043: BB4040SS
• 00821925028029: BB4000SS