DEVICE: VersaCut+ Tissue Morcellator with Inverted Handpiece (07290109140636)

Device Identifier (DI) Information

VersaCut+ Tissue Morcellator with Inverted Handpiece
VersaCut+ Tissue Morcellator with Inverted Handpiece
In Commercial Distribution

LUMENIS LTD.
07290109140636
GS1

1
600166524 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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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
Tissue morcellation system handpiece A hand-held component of a tissue morcellation system intended to be 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; a handpiece obturator, and a disposable remote drive cable may be included. Resected tissue may be removed through suction or manually 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K133272 000
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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 Record Status

2d552d21-4f73-4260-bd91-badf8aa37d61
July 06, 2018
3
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
Yes
No
Yes
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Customer Contact

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408-764-3000
xxx@xxx.xxx
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