FDA.reportPublic FDA data

neoClose 2 Anchor (Long Driver) US

Primary DI
05391529640552
Brand
neoClose 2 Anchor (Long Driver) US
Company
NEOSURGICAL LIMITED
Model
NCAALX2-U
Device description
Laparoscopy wound closure system pack consists of: 05391529640439; neoClose Anchor (Long Driver) x 2 US; Model Number NCAALX2-U
Published
2018-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142903000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142903000neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack USNeosurgical, Ltd.2014-11-12GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05391529640569PackageGS18In Commercial Distribution
05391529640552PrimaryGS10
05391529640439Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391529640569053915296405695391529640569
05391529640552053915296405525391529640552
05391529640439053915296404395391529640439

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic wound closure threadA 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.

Regulatory Flags#

DUNS number
896844250
Device count
15
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391529640460neoClose AnchorGuardNCAG-U2018-07-03
05391529640477neoClose AnchorGuardNCAG-U2018-07-03
05391529640569neoClose 2 Anchor (Long Driver) USNCAALX2-U2018-07-03
05391529640064neoClose AnchorGuide XL Port Closure Kit US NCAGXL-U2016-11-11
05391529640088neoClose AnchorGuide Regular Port Closure Kit x2 US NCAGRX2-U2016-11-11
05391529640101neoClose 2 AutoAnchor Pack US NCAAX2-U2016-11-11
05391529640125neoClose 4 AutoAnchor Pack US NCAAX4-U2016-11-11
05391529640163neoClose AnchorGuide 5/12 Port Closure Kit US (1 Port)NCAG512-U2016-11-11
05391529640194neoClose AnchorGuide 8/15 Port Closure Kit US (1 Port)NCAG815-U2016-11-11
05391529640224neoClose AnchorGuide 5/15 Port Closure Kit US (2 Port)NCAG515(2)-U2016-11-11
05391529640026neoClose AnchorGuide Regular Port Closure Kit US NCAGR-U2016-11-11
05391529640071neoClose AnchorGuide XL Port Closure Kit US NCAGXL-U2016-11-11
05391529640095neoClose AnchorGuide Regular Port Closure Kit x2 UNCAGRX2-U2016-11-11
05391529640118neoClose 2 AutoAnchor Pack US NCAAX2-U2016-11-11
05391529640132neoClose 4 AutoAnchor Pack US NCAAX4-U2016-11-11
05391529640170neoClose AnchorGuide 5/12 Port Closure Kit US (1 PNCAG512-U2016-11-11
05391529640200neoClose AnchorGuide 8/15 Port Closure Kit US (1 PNCAG815-U2016-11-11
05391529640231neoClose AnchorGuide 5/15 Port Closure Kit US (2 PNCAG515(2)-U2016-11-11

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