DEVICE: EBERLE (04050052025366)

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Device Record History
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Device Identifier (DI) Information
EBERLE
9141134
In Commercial Distribution
9141134
Eberle GmbH & Co. KG
04050052025366
GS1

1
315919220 *Terms of Use
Full Radius Resector 3,5
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
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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?
38654 Arthroscopic shaver system blade, reusable
A cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HRX Arthroscope
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K092977 000
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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

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Size Type Text
No Device Sizes
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Device Record Status
1928623c-e8e7-4c26-9c6f-9543b1c94901
May 04, 2023
3
June 16, 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
04050052029579 5 04050052025366 In Commercial Distribution
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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

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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

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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