ProTector PNS500-1

GUDID H816PNS5001

Needle Sheath Prop

CERTOL INTERNATIONAL, LLC

Surgical instrument containment holder, single-use, non-sterile

• Primary Device ID: H816PNS5001
• NIH Device Record Key: 8eb53960-117b-4a5c-b632-aff1b49ea15a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProTector
• Version Model Number: PNS500
• Catalog Number: PNS500-1
• Company DUNS: 095153714
• Company Name: CERTOL INTERNATIONAL, LLC
• Device Count: 500
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H816PNS5000 [Unit of Use]
HIBCC	H816PNS5001 [Primary]
HIBCC	H816PNS5002 [Package]; Package: Case Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052725

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-23

On-Brand Devices [ProTector]

• H816PNS5001: Needle Sheath Prop
• H816PNS1002: Needle Sheath Prop