Procedure Products Needle

GUDID B16032M18601

18 X TW (.050 X .040) MARKED - 2 part - needle

PROCEDURE PRODUCTS, INC.

Vascular catheter introduction needle

• Primary Device ID: B16032M18601
• NIH Device Record Key: c3a7fe28-5279-4417-bc07-929fe7788e5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Products Needle
• Version Model Number: 32M-1860
• Company DUNS: 151507563
• Company Name: PROCEDURE PRODUCTS, INC.
• Device Count: 1
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B16032M18601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K810859

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-07

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