neoClose AnchorGuide 8/15 Port Closure Kit US (1 P

GUDID 05391529640200

Laparoscopy wound closure system kit consists of: 05391529640187; neoClose AnchorGuide 8/15 US; Model Number NCA815-U; Qty 10 and 05391529640156; n

NEOSURGICAL LIMITED

Laparoscopic wound closure thread
Primary Device ID05391529640200
NIH Device Record Keyd82f64df-5be6-44e7-b11e-e865c1eb4452
Commercial Distribution StatusIn Commercial Distribution
Brand NameneoClose AnchorGuide 8/15 Port Closure Kit US (1 P
Version Model NumberNCAG815-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
GS105391529640194 [Primary]
GS105391529640200 [Package]
Contains: 05391529640194
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 2018-07-06 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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