DEVICE: VALVULOTOME (DETACHABLE TYPE) (04953170047671)

Device Identifier (DI) Information

VALVULOTOME (DETACHABLE TYPE)
C-0103B
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170047671
GS1

1
711789789 *Terms of Use
VALVULOTOME (DETACHABLE TYPE)
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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
Valvulotome A hand-held manual surgical instrument designed for cutting an anatomical valve or valves in situ (e.g., to slit a heart valve or to cut the valves within a vein to allow blood flow in the opposite direction). It is typically a flexible, plastic-coated metal shaft with a proximal handle and an extremely sharp cutting edge at the distal tip (e.g., the distal tip may terminate in a blade which is curved at 90 degrees to the shaft, or an assembly of several thin helicoidal blades that are rotated). This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
DWX STRIPPER, ARTERY, INTRALUMINAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K895878 000
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Sterilization

Yes
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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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

6488d7c4-5faf-4774-a925-aaf4fe9ec3fc
October 08, 2018
5
September 21, 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
14953170047678 1 04953170047671 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)

[?]
Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
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