8mm x 8mm Staple System

Basic Information

• Brand Name: 8mm x 8mm Staple System
• Primary DI: 00812926027500
• Version / Model: 500-08-001
• Company Name: Trilliant Surgical, LLC
• Labeler DUNS: 828829072
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-05
• Public Version: 7
• Public Version Date: 2022-04-06
• Public Version Status: Update
• Public Device Record Key: bd0c381a-af98-43cd-83f4-aaf989329279

Device Description

8mm Sniper Sterile Staple Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDR	Staple, Fixation, Bone	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35615	Surgical staple loading unit, non-cutting	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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812926027500	GS1

Premarket Submissions

Submission Number	Supplement Number
K162354	000

Device Sizes

Type	Value	Unit	Text
Width	8	Millimeter
Height	8	Millimeter