- Physicians Office Resource

Motorized Fixation Device 30 Absorbable Tacks
MaxTack - MAXTACK30

Device Description

An implantable bioabsorbable device intended to be used for the fixation of soft-tissue repair material (e.g., prosthetic silicone sheet, surgical mesh) during surgical repair and reconstruction of soft-tissue defects (e.g., ventral and groin hernia). It is not designed for dental or ophthalmic applications. It is in the form of a small cylinder with a rounded head and a tapered end made of synthetic polymer materials; it is available independently or preloaded in a disposable implantation device (e.g., motorized handpiece).

Environmental Conditions

Handling Environment Temperature - Degrees Fahrenheit

118.00
N/A

Storage Environment Atmospheric Pressure - KiloPascal

101.00
55.00

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
N/A

Storage Environment Temperature - Degrees Fahrenheit

118.00
N/A

Device Sizes

Length: 5 Millimeter

Length: 5 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OCW

Device Name: Endoscopic Tissue Approximation Device

Device Class: 2

Physical State: may include: delivery instrument, applier, holder, connector, threading tool, needle-loading tool, ring implant, pin implant, knot pusher, sutures, staples, clips, tackers, fasteners

Definition: To aid in endoscopically placing sutures, staples, clips, and other fastening tools through tissue.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Many methods to perform intended use. Insert instrument through endoscope at desired area of delivery.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Various tissues located within body cavities, hollow organs, and canals in GI and GU tract.

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Code: GDW

Device Name: Staple, Implantable

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 878.4750

Third Party Flag: N

Medical Specialty: SU

Device Identifiers

Device Id: 20884521826264

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521826267

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: PACK_OR_INNER_PACK

Device Id: 10884521826267

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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