DEVICE: PIRANHA (04055207063422)

Device Identifier (DI) Information

PIRANHA
49700113
In Commercial Distribution
49700113
Richard Wolf GmbH
04055207063422
GS1

3
315304071 *Terms of Use
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 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

[?]
Product Code Product Code Name
FJK SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
Hydrogen Peroxide
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
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

[?]
Size Type Text
Outer Diameter: 4.8 Millimeter
Length: 335 Millimeter
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Device Record Status

41725a92-15a1-402e-a017-dac94ed66620
March 12, 2019
5
June 28, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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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