DEVICE: n.a. (04048551099049)

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Device Record History
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Device Identifier (DI) Information
n.a.
26175BK
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551099049
GS1

1
315731430 *Terms of Use
Myoma Fixation Instrument, short
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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?
36235 Manual surgical rotary handpiece, reusable
A manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HET LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K945211 000
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Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Liquid Chemical
Ethylene Oxide
Hydrogen Peroxide
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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
b96bbae0-3277-46d1-ac35-5b5b1442f76e
September 20, 2021
4
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

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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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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