BD Quincke Spinal NRFit 400053

GUDID 50382904000535

NDL SP SSU 18G 3 1/2IN QUINCKE NRFIT

BECTON, DICKINSON AND COMPANY

Spinal needle, single-use

• Primary Device ID: 50382904000535
• NIH Device Record Key: 3880a84c-7a77-4e42-b5ff-da824f45ae50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Quincke Spinal NRFit
• Version Model Number: 400053
• Catalog Number: 400053
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904000530 [Primary]
GS1	30382904000531 [Package]; Contains: 00382904000530; Package: Shelfpack [25 Units]; In Commercial Distribution
GS1	50382904000535 [Package]; Contains: 00382904000530; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193131

FDA Product Code

• BSP: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-09
• Device Publish Date: 2022-06-01

On-Brand Devices [BD Quincke Spinal NRFit]

• 30382904009213: BD® Quincke Spinal NRFit™ Needle, 20G x 6 in.
• 50382904009200: BD® Quincke Spinal NRFit™ Needle, 20G x 3 in.
• 30382904000548: BD® Quincke Spinal NRFit™ Needle, 18G x 6 in.
• 50382904000528: BD® Quincke Spinal NRFit™ Needle, 18G x 3 in.
• 50382904000870: BD® Quincke Spinal NRFit™ Needle, 25G x 3 in.
• 50382904000818: BD® Quincke Spinal NRFit™ Needle, 25G x 4 11/16 in.
• 30382904000623: BD® Quincke Spinal NRFit™ Needle, 25G x 2 in.
• 30382904000609: BD® Quincke Spinal NRFit™ Needle, 22G x 7 in.
• 50382904000597: BD® Quincke Spinal NRFit™ Needle, 22G x 5 in.
• 30382904000579: BD® Quincke Spinal NRFit™ Needle, 22G x 3 in.
• 30382904009909: NDL SP SSU 20G 2 1/2IN QUINCKE NRFIT
• 50382904009897: NDL SP SSU 20G 1 1/2IN QUINCKE NRFIT
• 50382904000535: NDL SP SSU 18G 3 1/2IN QUINCKE NRFIT
• 30382904009244: BD® Quincke Spinal NRFit™ Needle, 27G x 3 1/2 in.
• 30382904009237: BD® Quincke Spinal NRFit™ Needle, 26G x 3 1/2 in.
• 30382904009220: BD® Quincke Spinal NRFit™ Needle, 23G x 3 1/2 in.
• 30382904001811: BD® Quincke Spinal NRFit™ Needle, 20G x 3 1/2 in.
• 50382904000887: BD® Quincke Spinal NRFit™ Needle, 25G x 3 1/2 in.
• 30382904000586: BD® Quincke Spinal NRFit™ Needle, 22G x 3 1/2 in.
• 30382904000562: BD® Quincke Spinal NRFit™ Needle, 22G x 2 1/2 in.
• 30382904000555: BD® Quincke Spinal NRFit™ Needle, 22G x 1 1/2 in.