DEVICE: Lapcap2 (05060484670002)

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Device Identifier (DI) Information

Lapcap2
LC2-STD
LC2-STD
LIFE CARE MEDICAL DEVICES LIMITED
05060484670002
GS1
1
A sterile, singe use, acrylic dome shaped device with a port for attachment of the suction system and septum for the insertion of a Veress needle. It assists in the blind passage of a 14G Veress needle to establish a pneumoperitoneum prior to laparoscopic procedures. The device is centered over the umbilicus, a suction hose is attached to the suction port and negative pressure applied. The abdomen rises, allowing the Veress needle to be inserted into the created space. Inert gas is delivered to replace the negative pressure.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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
Laparoscopic access suction dome A sterile dome-shaped device intended to facilitate laparoscopic-insufflation needle insertion by causing the anterior abdominal wall to separate from the underlying viscera using vacuum applied to the surface of the abdomen, thereby creating a space for the needle tip. It is typically made of synthetic polymer materials and is designed to be used with the hospital central vacuum system. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HIF Insufflator, Laparoscopic
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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

[?]
Size Type Text
Device Size Text, specify: Standard Size
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Device Status

In Commercial Distribution
June 08, 2016

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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
15060484670009 10 05060484670002 In Commercial Distribution Corrugated Cardboard
25060484670006 4 15060484670009 In Commercial Distribution Glued 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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+441273934222
quality@lcmd.co.uk
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