LIGACLIP

Basic Information

• Brand Name: LIGACLIP
• Primary DI: 10705036012818
• Version / Model: LT202
• Catalog Number: LT202
• Company Name: ETHICON ENDO-SURGERY, LLC
• Labeler DUNS: 044606982
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-24
• Public Version: 5
• Public Version Date: 2023-11-06
• Public Version Status: Update
• Public Device Record Key: 3b44e39b-eccb-416b-bfe7-13afb4282119

Device Description

LIGACLIP EXTRA Ligating Clip Cartridges: 20 Titanium Clips/ Cartridge (Medium)

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: MR Conditional
• 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
FZP	CLIP, IMPLANTABLE	General, Plastic Surgery	878.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35649	Ligation clip, metallic	A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30705036012812	GS1	CASE	720	In Commercial Distribution
Primary	10705036012818	GS1
Package	40705036012819	GS1	CASE	360	In Commercial Distribution
Package	20705036012815	GS1	BOX	15	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K830503	000