DIEGO

GUDID 00821925025974

PK DIEGO PWRD DISSECTOR BLADE IRRIGATING, SERRATED, BIPOLAR 4.8 MM DIAMETER 15 DEGREE CONVEX (6/Pk)

Gyrus Acmi, Inc.

Metal/carbide ENT bur, single-use

• Primary Device ID: 00821925025974
• NIH Device Record Key: d94afd86-3873-4cff-945b-b1eaead6b9bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIEGO
• Version Model Number: 70139010
• 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	00821925025974 [Package]; Contains: 00821925034259; Package: [6 Units]; In Commercial Distribution
GS1	00821925034259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K034004

FDA Product Code

• ERL: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-02
• Device Publish Date: 2024-07-25

On-Brand Devices [DIEGO]

• 00821925025394: PK DIEGO PWRD DISSECTOR BLADE IRRIGATING, AGGRSV, BIPOLAR 3.0 MM DIAMETER STRAIGHT (6/PK)
• 00821925025950: DIEGO PK PWRD DISSECTOR BLADE ADENOID, SERRATED, BIPOLAR 4.8 MM DIAMETER CONVEX 40 DEGREES, IRRI
• 00821925025943: PK DIEGO PWRD DISSECTOR BLADE IRRIGATING, SERRATED, BIPOLAR 4.8 MM DIAMETER CONCAVE 15 DEGREES (
• 00821925025967: PK DIEGO PWRD DISSECTOR BLADE IRRIGATING, SERRATED, BIPOLAR 4.8 MM DIAMETER CONCAVE 40 DEGREES (
• 00821925025974: PK DIEGO PWRD DISSECTOR BLADE IRRIGATING, SERRATED, BIPOLAR 4.8 MM DIAMETER 15 DEGREE CONVEX (6/
• 00821925025936: PK DIEGO PWRD DISSECTOR BLADE IRRIGATING, SERRATED, BIPOLAR 4.8 MM DIAMETER STRAIGHT (6/Pk)
• 00821925025929: DIEGO PK PWRD DISSECTOR BLADE IRRIGATING, SERRATED, BIPOLAR 4.2 MM DIAMETER STRAIGHT (6/Pk)
• 00821925026926: DIEGO PK FOOTSWITCH
• 00821925026599: DIEGO PK CONSOLE, REFURBISHED
• 00821925011427: DIEGO PK CONSOLE