Procedure Products Needles

GUDID B16097211

18 Gauge Filter Pack

PROCEDURE PRODUCTS, INC.

Vascular catheter introduction needle Vascular catheter introduction needle

• Primary Device ID: B16097211
• NIH Device Record Key: 567a074f-c102-40a3-98a6-e0ab7753fcb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Products Needles
• Version Model Number: 9721
• 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	B16097211 [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: 2017-09-12

On-Brand Devices [Procedure Products Needles]

• B16097211: 18 Gauge Filter Pack
• B1605518291: 2 PART, 7CM, SELDINGER, KSDN PLATE
• B1603293552: 19ga, 1-wall needle
• B160311827P1: NEEDLE, W/O BASEPLATE 7CM 18g W/ PLUG
• B1603118151: NEEDLES, W/O BASEPLATE 3.8CM 18g
• B1602293572: 19ga, 7cm, 1-part needle
• B1602118352: NEEDLE, BSDN PLATE 1 PART 9 CM 18g
• B160211827P1: 18 GA needle, 7cm, BSDN, with Plug
• B1602018401: NEEDLE, 2 PART, 10.2cm, 18g, MODIFIED POTTS
• B1602018221: Needle, 18ga, 5.7cm, 2-part