- Physicians Office Resource

Fixation Device;30 Violet Absorbable Tacks
AbsorbaTack - ABSTACK30X

Device Description

A sterile, hand-held, manual surgical instrument intended to be used during abdominal, gynaecological, paediatric, and thoracic endoscopic (i.e., endotherapy) surgery for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue during a laparoscopic procedure; it has no cutting function and may be used during open surgery. The device operates by a manual mechanism (e.g., trigger mechanism) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

Environmental Conditions

Handling Environment Temperature - Degrees Fahrenheit

120.00
N/A

Device Sizes

Outer Diameter: 5 Millimeter

Outer Diameter: 5 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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: 20884521184210

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521184213

Package Quantity: 6

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CASE

Device Id: 10884521184213

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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