DEVICE: Diego Elite (00821925035690)

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Device Record History
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Device Identifier (DI) Information
Diego Elite
MBUR3060DSF
In Commercial Distribution

Gyrus ACMI, LLC
00821925035690
GS1

1
007198742 *Terms of Use
BURR, 3MM, DIAMOND FINE 10MM FIXED EXPOSURE Diego Elite Drill
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45527 Diamond ENT bur, single-use
A rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EQJ BUR, EAR, NOSE AND THROAT
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
ac74bf84-c916-4025-b1de-912a6b10f3fa
September 02, 2024
4
September 13, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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