DIEGO

Basic Information

• Brand Name: DIEGO
• Primary DI: 00821925033894
• Version / Model: 70139000
• Company Name: Gyrus ACMI, LLC
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-25
• Public Version: 3
• Public Version Date: 2025-01-07
• Public Version Status: Update
• Public Device Record Key: 99576f9a-56a6-4aa1-8914-1b24af3c3a2e

Device Description

DIEGO PK PWRD DISSECTOR BLADE IRRIGATING, SERRATED, BIPOLAR 4.2 MM DIAMETER STRAIGHT (6/PK)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Ear, Nose, Throat	874.4250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34848	Metal/carbide ENT bur, single-use	A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00821925025929	GS1		6	In Commercial Distribution
Primary	00821925033894	GS1

Premarket Submissions

Submission Number	Supplement Number
K034004	000