DEVICE: Diego Elite (00821925035607)

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Device Record History
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Device Identifier (DI) Information
Diego Elite
MDHP200
In Commercial Distribution

Gyrus ACMI, LLC
00821925035607
GS1

1
007198742 *Terms of Use
DRILL HANDPIECE BASE Diego Elite Drill
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
36865 Arthroscopic shaver system handpiece, pneumatic
A handle with attached cutting blade that is a component of a pneumatically-powered shaver system designed for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is typically connected to and regulated by a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and is used in combination with appropriate endoscopic devices. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ERL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K152744 000
No CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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
63d113e9-6938-41a3-aa42-68e8ed711c5f
September 02, 2024
4
April 16, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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