DEVICE: ENDOSPINE (04048551234594)

Device Identifier (DI) Information

ENDOSPINE
28163DXH
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551234594
GS1

1
315731430 *Terms of Use
ENDOSPINE® Working Insert
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37085 Rigid endoscope working guide
An endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. 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 [?]
K993540 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Hydrogen Peroxide
Ethylene Oxide
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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

1ea88ce2-e0c0-4b56-8aa2-3b5e359d5e9d
July 06, 2018
3
September 23, 2016
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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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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