BURR, 4MM ROUND CUTTING 10-25MM VAR EXPOSURE Diego Elite Drill 60MM

GUDID 00821925036512

BURR, 4MM ROUND CUTTING 10-25MM VAR EXPOSURE Diego Elite Drill 60MM, Length of burrSTD, Use with Sho

Gyrus Acmi, Inc.

Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use Metal/carbide ENT bur, single-use

• Primary Device ID: 00821925036512
• NIH Device Record Key: 54ea30fc-573a-48f5-8279-790ff5a27018
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BURR, 4MM ROUND CUTTING 10-25MM VAR EXPOSURE Diego Elite Drill 60MM
• Version Model Number: MBUR4060FRCV
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00821925036512 [Primary]

FDA Product Code

• EQJ: BUR, EAR, NOSE AND THROAT

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: 2020-03-04
• Device Publish Date: 2020-02-25

Devices Manufactured by Gyrus Acmi, Inc.

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• 00810008180990 - nCare: 2023-10-02 nCare,D ,2 DRCT SDI, DICOM, RCRDG
• 00810008180501 - nCare: 2023-09-25 nCare, Sgl,Direct SDI,DICOM,Rcrdg
• 00810008180921 - nCare: 2023-09-25 nCare, Dual,ELA x 2,DICOM,Rcrdg
• 00810008180952 - nCare: 2023-09-25 nCare, SNGL,DRCT SDI,DICOM
• 00810008180969 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM
• 00810008180976 - nCare: 2023-09-25 nCare, SNGL, ELA, DICOM, RCRDG
• 00821925036406 - USA Elite: 2023-07-26 ACMI USA Elite System and USA Series Knife Electrode 24 Fr (8mm)