DEVICE: neoClose AnchorGuide 5/15 Port Closure Kit US (2 Port) (05391529640224)
Device Identifier (DI) Information
neoClose AnchorGuide 5/15 Port Closure Kit US (2 Port)
NCAG515(2)-U
In Commercial Distribution
NEOSURGICAL LIMITED
NCAG515(2)-U
In Commercial Distribution
NEOSURGICAL LIMITED
Laparoscopy wound closure system kit consists of:
05391529640002; neoClose AnchorGuide 5/12 & 8/15 US; Model Number NCA515-U; Qty 10
and
05391529640217; neoClose 4 AutoAnchor Pack US; Model Number NCAA4-U; Qty 10
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60390 | 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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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GCJ | Laparoscope, General & Plastic Surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K142903 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
20fa8941-b0f9-4268-8e2b-2557e2940d52
July 06, 2018
3
November 11, 2016
July 06, 2018
3
November 11, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
05391529640231 | 4 | 05391529640224 | In Commercial Distribution | Shipper |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined