ProTector

Basic Information

• Brand Name: ProTector
• Primary DI: H816PNS1001
• Version / Model: PNS100
• Catalog Number: PNS100-1
• Company Name: CERTOL INTERNATIONAL, LLC
• Labeler DUNS: 095153714
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 6
• Public Version Date: 2022-11-01
• Public Version Status: Update
• Public Device Record Key: 4c1d66fd-45de-455e-a7da-a1c8a6215dfe

Device Description

Needle Sheath Prop

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61665	Surgical instrument containment holder, single-use, non-sterile	A non-sterile device intended to be used in the operating room (OR) by staff to safely contain/support a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] to avoid damage to the instrument during surgery and/or to enable easy transfer/handling of the instrument at reduced risk of injury. It is available in various forms (e.g., rack, rest, puncture cushion, pocket, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	H816PNS1002	HIBCC	Case Box	10	In Commercial Distribution
Primary	H816PNS1001	HIBCC
Unit of Use	H816PNS1000	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K052725	000