Procedure Products Syringes

GUDID B1603118351

NEEDLES, W/O BASEPLATE 9CM 18g

PROCEDURE PRODUCTS, INC.

Vascular catheter introduction needle Vascular catheter introduction needle

• Primary Device ID: B1603118351
• NIH Device Record Key: 870d6aa9-95a7-43fc-8a2a-66cf01a07d1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Procedure Products Syringes
• Version Model Number: 31-1835
• 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	B1603118351 [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

On-Brand Devices [Procedure Products Syringes]

• B160984930GR1: PAIR 10CC STANDARD SYRINGES RED/GRN
• B1605318G1: 20cc, Luer-Lock Control Syringe, Green Plunger
• B1605030W771: 30ML/CC LL WHITE POLYCARB SYRINGE, High Alert Label
• B1605010G1: 10ML/CC LL GREEN POLYCARB SYRINGE
• B1605006G1: 6ml/cc Polycarbonate Syringe, Green plunger, Luer-lock
• B1605003W1: 3ml/cc Polycarbonate Syringe, White plunger, Luer-lock
• B1605003V1: 3ml/cc Polycarbonate Syringe, Violet plunger, Luer-lock
• B1605003R1: 3ml/cc Polycarbonate Syringe, Red Plunger, Luer-lock
• B1605001G1: 1ml/cc Polycarbonate Syringe, Green plunger, Luer-lock
• B1604950Y1: 20CC LOCK STANDARD SYRINGE,YELLOW
• B1604950W872: 20cc syringe, white plunger, flush label
• B1604940R1: 10cc luer-lock syringe, air-safe red plunger
• B1604930Y321: 10cc Syringe, yellow plunger, Heparin Label
• B1604930Y1: Standard 10cc Lock Syringe, Yellow plunger
• B1604930V1: 10cc Standard syringe, Violet plunger
• B1604930G21: 10CC Luer Lock GREEN SYRINGE W/ CONTRAST LABEL
• B1604930B1: 10cc Standard Lock Syringe, Blue Plunger
• B1604920Y1: 10cc Syringe, Yellow palm-pad plunger
• B1604920G2: 10cc syringe, green palm-pad plunger
• B1604410R1: 5cc, Standard Syringe, Red Plunger
• B1604410B1: 5CC LOCK STANDARD SYRINGE, BLUE
• B1603118351: NEEDLES, W/O BASEPLATE 9CM 18g