DEVICE: n.a. (04048551051580)

Device Identifier (DI) Information

n.a.
11572A
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551051580
GS1

1
315731430 *Terms of Use
Mini Straight Forw. Telescope 0°, 0.8 mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Sialendoscope An endoscope with a slender semiflexible inserted portion intended for the visual examination and treatment of the salivary ducts. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used in combination with special instruments (e.g., forceps, laser probes, stone extractors) to locate and extract/treat a salivary stone (sialolithiasis) and/or a stricture (sialostenosis) in the submandibular, parotid, and/or sublingual salivary duct. This is a reusable device intended to be sterilized before use.
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FDA Product Code

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Product Code Product Code Name
GCJ Laparoscope, general & plastic surgery
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K012527 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
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Storage and Handling

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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

16863240-7ba6-4126-83fb-45c457c3d1fa
July 06, 2018
3
September 23, 2016
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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
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

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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