FDA.reportPublic FDA data

neoClose 4 AutoAnchor Pack US

Primary DI
05391529640132
Brand
neoClose 4 AutoAnchor Pack US
Company
NEOSURGICAL LIMITED
Model
NCAAX4-U
Device description
Laparoscopy wound closure system pack consists of: 05391529640057; neoClose AutoAnchor x4 Pack US; Model Number NCA4-U; Qty 15.
Published
2016-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
05391529640132PackageGS18In Commercial Distribution
05391529640125PrimaryGS10
05391529640057Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05391529640132053915296401325391529640132
05391529640125053915296401255391529640125
05391529640057053915296400575391529640057

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
896844250
Device count
15
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05391529640460neoClose AnchorGuardNCAG-U2018-07-03
05391529640552neoClose 2 Anchor (Long Driver) USNCAALX2-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
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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