New Wave Endo-Surgery Inc.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Instrument, Ligature Passing And Knot Tying (HCF) (2)

Premarket Exempt

Clear

M-Close Kit - 00850009417022 Catalog Number : 27-101

Device Description : The device is a disposable, ligature passing, suturing apparatus and needle guid 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.

Device Class :

Duns Number: 089533899

Premarket Exempt : No

Product Code : HCF

Prescription Use : Yes

Device Count : 1

M-Close Kit - 00850009417213 Catalog Number : 27-108

Device Description : The device is a disposable, ligature passing, suturing apparatus and needle guid 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 provided in the kit for use as a primary dressing for the surgical incision as well as a slip-tip syringe.