Loading Unit with Polysorb Staples
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Device Description
A bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is available in a variety of designs (e.g., screw-, punch-, staple-like) and is made of a polymer that can be chemically degraded via natural body processes. It is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized applicator which may be included.
Environmental Conditions
- 130.00
- N/A
Device Sizes
- Height: .200 Inch
- Length: 55 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 IdentifiersDevice Id: 20884521047607
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10884521047600
Package Quantity: 6
Package Discontinue Date: 12/9/2020 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: CASE
Device Id: 10884521047600
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