SILS

Basic Information

• Brand Name: SILS
• Primary DI: 10884523000627
• Version / Model: SILSHOOK36
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: bbeb36cd-e27a-4978-a52d-39130c961ad3

Device Description

Hook

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46421	Rigid endoscopic scissors, reusable	A hand-held rigid device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of stainless steel and is designed as a long pair of parallel sliding arms whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a ringed handle at the proximal end. It is typically introduced into the body cavity through the working channel of the endoscope. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884523000624	GS1	CASE	6	In Commercial Distribution
Primary	10884523000627	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091869	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	5	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 120 Degrees Fahrenheit