DEVICE: neoClose AnchorGuide Regular Port Closure Kit x2 US (05391529640088)

Device Identifier (DI) Information

neoClose AnchorGuide Regular Port Closure Kit x2 US
NCAGRX2-U
In Commercial Distribution

NEOSURGICAL LIMITED
05391529640088
GS1

1
896844250 *Terms of Use
Laparoscopy wound closure system kit consists of: 05391529640002; neoClose AnchorGuide 5/12 & 8/15 US; Model Number NCA5/15-U; Qty 10 and 05391529640057; neoClose AutoAnchor x4 Pack US; Model Number NCA4-U; Qty 10.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
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
Laparoscopic wound closure thread A sterile, bioabsorbable, implantable, device intended to be used exclusively during laparoscopic surgery to approximate subcutaneous tissue after removal of the laparoscopic sleeve/port. It consists of a suture with an attached short tag (anchor), and often includes a plastic guide which can take different forms depending on the method of laparoscopic entry, and a metal (e.g., stainless steel) and/or plastic pusher. The guide and pusher are used to deliver the suture so that the tag is deep to the wound, with the suture trailing so that it can be ligated on removal of the laparoscopic sleeve/port.
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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 [?]
K142903 000
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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
No Device Sizes
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Device Record Status

79394e83-5c94-46b9-a85e-0500cad93085
July 06, 2018
3
November 11, 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
05391529640095 4 05391529640088 In Commercial Distribution Shipper
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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
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Customer Contact

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No Customer Contact currently defined
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