ASSI

Basic Information

• Brand Name: ASSI
• Primary DI: 00841645117391
• Version / Model: ASSI.BRC5
• Company Name: ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
• Labeler DUNS: 055870299
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-07
• Public Version: 1
• Public Version Date: 2020-07-15
• Public Version Status: New
• Public Device Record Key: 509627a2-0fe2-425e-a901-2162beb4d73d

Device Description

Breast Reduction Compression Device tourniquet, for approx. 500-800gm reduction 5/SET STERILE

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	878.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17230	Tourniquet cuff, reusable	A band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841645117391	GS1