M-Close Kit 27-101

GUDID 00850009417053

The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall which is non-powered, hand-held, and hand-manipulated, intended to be used in various general surgical procedures. The device includes a ligature carrier pathway, needle guide, two needles, reference plane T-Bar, and a guidewire. The handle of the device provides two diametrically opposed enclosed guideways for the advancement and retraction of the needles under manual control of a plunger located at the proximal end of the device.As part of the M-Close convenience kit, a Nerve Block Needle is included for the administration of local anesthetic agents to provide regional and local anesthesia. A Telfa Antimicrobial, non-Adherent Pad is also provided in the kit for use as a primary dressing for the surgical incision.

New Wave Endo-Surgery Inc.

Suturing unit, single-use

• Primary Device ID: 00850009417053
• NIH Device Record Key: fb8cd1a3-d94c-4753-847d-2eb8d2113976
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M-Close Kit
• Version Model Number: 27-101
• Catalog Number: 27-101
• Company DUNS: 089533899
• Company Name: New Wave Endo-Surgery Inc.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com
• Phone: 8887008890
• Email: info@newwaveendo.com

Device Dimensions

• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter
• Outer Diameter: 12 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry environment

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850009417022 [Primary]
GS1	00850009417053 [Package]; Contains: 00850009417022; Package: Single unit box [1 Units]; In Commercial Distribution
GS1	00850009417060 [Package]; Package: 5 unit box [5 Units]; In Commercial Distribution
GS1	00850009417107 [Package]; Contains: 00850009417060; Package: Shipping carton [12 Units]; In Commercial Distribution

FDA Product Code

• HCF: Instrument, Ligature Passing And Knot Tying

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-29
• Device Publish Date: 2020-09-21

On-Brand Devices [M-Close Kit]

• 00850009417220: The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdomi
• 00850009417053: The device is a disposable, ligature passing, suturing apparatus and needle guide for the abdomi