DEVICE: MICROKERATOME Disposable Tubing (04050555000839)

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Device Identifier (DI) Information

MICROKERATOME Disposable Tubing
1
5070063
Technolas Perfect Vision GmbH
04050555000839
GS1
1
Provides a connection between the microkeratome head and the vacuum (or suction) pump. The function of the tubing is to provide a conduit for suction to the eye during lamellar surgery.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Keratome, line-powered A mains electricity (AC-powered) ophthalmic surgical instrument intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant. This device will typically have a special blade mounted to it for the cutting process.
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FDA Product Code

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Product Code Product Code Name
HNO Keratome, Ac-Powered
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 5 and 35 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 24, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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+4989940040
info@technolaspv.com
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