Procedure Products Needle 57-0387

GUDID B1605703871

KSDN PLATE NEEDLE (BX 25) 1 PART 7CM

PROCEDURE PRODUCTS, INC.

Vascular catheter introduction needle

• Primary Device ID: B1605703871
• NIH Device Record Key: a08d6f15-957c-4042-b6de-e6f4ad847e29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Products Needle
• Version Model Number: 57-0387
• Catalog Number: 57-0387
• 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	B1605703871 [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: 2018-02-12

On-Brand Devices [Procedure Products Needle]

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• B1603118601: NEEDLES, W/O BASEPLATE, 15CM 18g
• B1603118271: Seldinger Needle, 18ga x 7cm
• B1603118222: NEEDLE, W/O BASEPLATE 5.7CM 18g
• B1602118271: Seldinger Needle, 18ga x 7cm
• B1602018271: Potts Needle, 18ga x 7cm
• B1603118451: NEEDLE, W/O BASEPLATE, 11CM 18g