DEVICE: VersaCut+ Tissue Morcellator with Regular Handpiece (07290109140643)

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Device Identifier (DI) Information

VersaCut+ Tissue Morcellator with Regular Handpiece
VersaCut+ Tissue Morcellator with Regular Handpiece

LUMENIS LTD.
07290109140643
GS1
1
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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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
Tissue morcellation system handpiece A hand-held component of a tissue morcellation system used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery. It typically consists of a high-speed rotating blade in a holder, and is connected via cable to a control unit used to regulate blade speed and torque. Resected tissue is usually removed through the core of the blade with a grasping instrument. This is a single-use device.
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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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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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 Status

In Commercial Distribution
August 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)

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No
No
None
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Production Identifier(s) in UDI

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No
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No
Yes
No CLOSE

Customer Contact

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408-764-3000
xxx@xxx.xxx
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