DIEGO

GUDID 00821925026926

DIEGO PK FOOTSWITCH

Gyrus Acmi, Inc.

Electrosurgical handpiece, reusable

• Primary Device ID: 00821925026926
• NIH Device Record Key: cc3b0453-b16b-4901-8d8c-03cfa56716fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIEGO
• Version Model Number: 70339054
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925026926 [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: false

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