ProTector PNS500-1

GUDID H816MPNS5002

Needle Sheath Prop

MicroCare, LLC

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• Primary Device ID: H816MPNS5002
• NIH Device Record Key: 68fc959f-01d8-42b4-a95f-7fb86837de65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProTector
• Version Model Number: PNS500
• Catalog Number: PNS500-1
• Company DUNS: 118518186
• Company Name: MicroCare, 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	H816MPNS5000 [Unit of Use]
HIBCC	H816MPNS5001 [Primary]
HIBCC	H816MPNS5002 [Package]; Contains: H816MPNS5001; Package: Case Box [6 Units]; In Commercial Distribution
HIBCC	H816PNS5001 [Previous]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-03
• Device Publish Date: 2022-10-26

On-Brand Devices [ProTector]

• H816MPNS5002: Needle Sheath Prop
• H816MPNS1002: Needle Sheath Prop