AngioSystems Sharp Cup

Basic Information

• Brand Name: AngioSystems Sharp Cup
• Primary DI: 00816611020029
• Version / Model: 1036
• Company Name: ANGIOSYSTEMS, INCORPORATED
• Labeler DUNS: 144884467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-15
• Public Version: 4
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 6c99adb1-f6b7-4a24-862e-978ec9657eea

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
KKX	Drape, Surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34957	Surgical drape clip, reusable	A surgical instrument with two blades joined at their midpoint or made from a single alpha-shaped part, designed to temporarily attach or hold a drape(s), or to hold a drape to other devices, during a surgical procedure. It is typically designed with flat gripping blades so as not to harm the material of the drape. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00816611020050	GS1		12	In Commercial Distribution
Primary	00816611020029	GS1

Premarket Submissions

Submission Number	Supplement Number
K843260	000