Endo Clip

Basic Information

• Brand Name: Endo Clip
• Primary DI: 10884521057807
• Version / Model: 176615
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-30
• Public Version: 8
• Public Version Date: 2023-03-16
• Public Version Status: Update
• Public Device Record Key: 379d9f9b-38a0-48ec-82b6-1c965d399755

Device Description

Clip Applier

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	20884521057804	GS1	CASE	6	In Commercial Distribution
Primary	10884521057807	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K143644	000
K954435	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Height,Medium/Large,N/A;
Outer Diameter	10	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit