DEVICE: PIRANHA (04055207063422)

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Device Identifier (DI) Information

PIRANHA
49700113
49700113
Richard Wolf GmbH
04055207063422
GS1
3
ROTATIONS-MORCELLATOR Ø 4.8MM WL 335MM for MORCESCOPE, for morcellation following laser prostate enucleation, sterile
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Tissue morcellation system An assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the speed/torque of the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch.
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FDA Product Code

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Product Code Product Code Name
FJK SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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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 Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 5 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 4.8 Millimeter
Length: 335 Millimeter
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Device Status

In Commercial Distribution
June 28, 2017

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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: 04055207049747 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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