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
- 130.00
- N/A
Device Sizes
- 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 IdentifiersDevice 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