ITL Essential Standard Quiver

Basic Information

• Brand Name: ITL Essential Standard Quiver
• Primary DI: 19555240401141
• Version / Model: A100398
• Catalog Number: A100398
• Company Name: ITL ASIA PACIFIC SDN. BHD.
• Labeler DUNS: 597723837
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-25
• Public Version: 1
• Public Version Date: 2019-06-03
• Public Version Status: New
• Public Device Record Key: 23b3b5c6-6bff-4e08-8788-d9e11e691353

Device Description

Standard quiver, PVC loop, polypropylene, individually packaged and sterile. Device Intended Use: Holder for electrosurgical diathermy system conducting unit and/or other long instruments during surgery. For single use only.

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
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45686	Electrosurgical handpiece/electrode holder, single-use	A device intended to be used to house or fix an active electrosurgical handpiece/pen with its electrode when not being used by the surgeon during the surgical procedure. This is to secure the conducting unit, especially the electrode, within the sterile operating zone and protect it against potential adverse events. The holder will typically be fastened to an object within the sterile field (e.g., a drape, anaesthesia dividing arm, operating table). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	19555240400748	GS1	Carton	30	In Commercial Distribution
Primary	19555240401141	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K153472	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away From Direct Sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry