Lariat

Basic Information

• Brand Name: Lariat
• Primary DI: M95530060
• Version / Model: RS
• Company Name: SENTREHEART, INC
• Labeler DUNS: 068810802
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 743f3091-e5a7-4bbb-9a2f-fa0068e6fb11

Device Description

Suture Delivery Device

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	878.4800	1
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	878.5000	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62314	Open-surgery ligature loop	A sterile implantable suture-loop intended to be used to constrict (ligate) or approximate tissue during an open-surgical procedure. The ligature is made of polyester material and is typically pre-knotted. It is applied using a dedicated, disposable, hand-held ligator (included) which allows access to difficult areas, and which may be used with a dedicated guide sheath (not included).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M95530060	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K153096	000