DEVICE: VELOCITY ALPHA ™ (04251388956847)

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Device Record History
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Device Identifier (DI) Information
VELOCITY ALPHA ™
foot control, electric, incl. 3 m cable and bar for foot switch VMME-FS-H
In Commercial Distribution
VAFC
adeor Medical AG
04251388956847
GS1

1
341188943 *Terms of Use
No description.
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Device Characteristics
MR Unsafe
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?
44491 Multi-purpose surgical power tool system, line-powered
An assembly of devices designed to resect bones, tough tissues (e.g., cartilage, ligaments), and soft tissues during a surgical procedure; it is not dedicated to a specific clinical application. It includes a mains electricity (AC-powered) control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, saw blades, burs, milling cutters, shavers, screwdriver bits, guide wires).
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K191479 000
No CLOSE

Sterilization
No
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
9a16a53b-bc6a-420f-93ac-c289bb0b95f7
May 26, 2023
2
June 10, 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

[?]
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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