DEVICE: Ultimate Laparoscopic Suction/Irrigation Set, Single spike (05051223005773)

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Device Identifier (DI) Information

Ultimate Laparoscopic Suction/Irrigation Set, Single spike
PS3851ULT
PS3851ULT
PURPLE SURGICAL INTERNATIONAL LIMITED
05051223005773
GS1
1
Suction / Irrigation Set can be used during a variety of laparoscopic procedures to irrigate and remove fluid from the operating site, in the function of one instrument.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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
Surgical irrigation/aspiration tubing set A collection of sterile, flexible, double-bore tubing, and associated items (typically includes clamps, filters, spikes, and connectors), used as twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution to a surgical field through one bore and provide aspiration (suction) through the other during a surgical procedure (e.g., tissue/bone morcellation, ENT, neuro and general surgery). The tubing is made of synthetic material and is of a fixed diameter that may be specific to the requirements of the clinical application for which it is intended. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HET Laparoscope, Gynecologic (And Accessories)
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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
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 320 Millimeter
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Device Status

In Commercial Distribution
September 17, 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
35051223005774 10 05051223005773 In Commercial Distribution Shipping carton
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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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Yes
No
Yes
No
No CLOSE

Customer Contact

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+441923839333
mail@purplesurgical.com
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