- Physicians Office Resource

Loading Unit
PI - 3930A

Device Description

A unit containing non-bioabsorbable surgical staples (implantable and typically U-shaped lengths of wire made of implant grade metal) designed to be used with a surgical stapler (not included) to mechanically fasten internal tissues together (e.g., the subcuticular closure of skin or the approximation of the ends of bowel) to facilitate healing typically in abdominal, thoracic, gynaecologic, orthopaedic, or plastic and reconstructive surgery. The unit is designed to deploy the staples in multiples (e.g., as a row of staples) and is often referred to as a single-use loading unit (SULU) or reload.

Environmental Conditions

Handling Environment Temperature - Degrees Fahrenheit

130.00
N/A

Device Sizes

Height: 4.8 Millimeter

Length: 90 Millimeter

Height: 4.8 Millimeter
Length: 90 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: 20884521066899

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10884521066892

Package Quantity: 12

Package Discontinue Date: 9/3/2020 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: CASE

Device Id: 10884521066892

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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