neoClose AnchorGuide XL Port Closure Kit US

GUDID 05391529640071

Laparoscopy wound closure system kit consists of: 05391529640040; neoClose AnchorGuide12/15 & XL US; Model Number NCAXL-U; Qty 10 and 0539152964005

NEOSURGICAL LIMITED

Laparoscopic wound closure thread
Primary Device ID05391529640071
NIH Device Record Key6e80ef66-2a86-4b0e-bdf4-30b0f3080d0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameneoClose AnchorGuide XL Port Closure Kit US
Version Model NumberNCAGXL-U
Company DUNS896844250
Company NameNEOSURGICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105391529640064 [Primary]
GS105391529640071 [Package]
Contains: 05391529640064
Package: Shipper [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-11-11

Devices Manufactured by NEOSURGICAL LIMITED

05391529640477 - neoClose AnchorGuard2018-08-03 Laparoscopy wound closure system guide consists of: 05391529640422; neoClose AnchorGuard; Model Number NCAG-U
05391529640569 - neoClose 2 Anchor (Long Driver) US2018-08-03 Laparoscopy wound closure system pack consists of: 05391529640439; neoClose Anchor (Long Driver) x 2 US; Model Number NCAALX2-U
05391529640026 - neoClose AnchorGuide Regular Port Closure Kit US 2018-07-06 Laparoscopy wound closure system kit consists of: 05391529640002; neoClose AnchorGuide 5/12 & 8/15 US; Model Number NCA515-U; Qt
05391529640071 - neoClose AnchorGuide XL Port Closure Kit US 2018-07-06Laparoscopy wound closure system kit consists of: 05391529640040; neoClose AnchorGuide12/15 & XL US; Model Number NCAXL-U; Qty 10 and 0539152964005
05391529640071 - neoClose AnchorGuide XL Port Closure Kit US 2018-07-06 Laparoscopy wound closure system kit consists of: 05391529640040; neoClose AnchorGuide12/15 & XL US; Model Number NCAXL-U; Qty
05391529640095 - neoClose AnchorGuide Regular Port Closure Kit x2 U2018-07-06 Laparoscopy wound closure system kit consists of: 05391529640002; neoClose AnchorGuide 5/12 & 8/15 US; Model Number NCA5/15-U; Q
05391529640118 - neoClose 2 AutoAnchor Pack US 2018-07-06 Laparoscopy wound closure system pack consists of: 05391529640019; neoClose AutoAnchor x2 Pack US; Model Number NCA2-U Qty 15
05391529640132 - neoClose 4 AutoAnchor Pack US 2018-07-06 Laparoscopy wound closure system pack consists of: 05391529640057; neoClose AutoAnchor x4 Pack US; Model Number NCA4-U; Qty 15.
05391529640170 - neoClose AnchorGuide 5/12 Port Closure Kit US (1 P2018-07-06 Laparoscopy wound closure system kit consists of: 05391529640149; neoClose AnchorGuide 5/12 US; Model Number NCA512-U; Qty 10

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