neoClose AnchorGuide 5/15 Port Closure Kit US (2 P

GUDID 05391529640231

Laparoscopy wound closure system kit consists of: 05391529640002; neoClose AnchorGuide 5/12 & 8/15 US; Model Number NCA515-U; Qty 10 and 0539152964

NEOSURGICAL LIMITED

Laparoscopic wound closure thread

• Primary Device ID: 05391529640231
• NIH Device Record Key: 20fa8941-b0f9-4268-8e2b-2557e2940d52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neoClose AnchorGuide 5/15 Port Closure Kit US (2 P
• Version Model Number: NCAG515(2)-U
• Company DUNS: 896844250
• Company Name: NEOSURGICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391529640224 [Primary]
GS1	05391529640231 [Package]; Contains: 05391529640224; Package: Shipper [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142903

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-11

Devices Manufactured by NEOSURGICAL LIMITED

• 05391529640477 - neoClose AnchorGuard: 2018-08-03 Laparoscopy wound closure system guide consists of: 05391529640422; neoClose AnchorGuard; Model Number NCAG-U
• 05391529640569 - neoClose 2 Anchor (Long Driver) US: 2018-08-03 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 U: 2018-07-06 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 P: 2018-07-06 Laparoscopy wound closure system kit consists of: 05391529640149; neoClose AnchorGuide 5/12 US; Model Number NCA512-U; Qty 10