BD PrecisionGlide 409408

GUDID 50382904094084

NEEDLE BIOPSY S/SU 20GA 2-1/2IN BREAST

BECTON, DICKINSON AND COMPANY

Body aspiration needle, single-use Body aspiration needle, single-use

• Primary Device ID: 50382904094084
• NIH Device Record Key: 3f07e8a7-ebdc-4da7-a8a1-1565a8b52a9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD PrecisionGlide
• Version Model Number: 409408
• Catalog Number: 409408
• Company DUNS: 001292192
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 10
• DM Exempt: true
• 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

Operating and Storage Conditions

• 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	00382904094089 [Unit of Use]
GS1	30382904094080 [Primary]
GS1	50382904094084 [Package]; Contains: 30382904094080; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K881697

FDA Product Code

• IZH: System, x-ray, mammographic

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: 2016-09-16

On-Brand Devices [BD PrecisionGlide]

• 50382904094091: NEEDLE BIOPSY S/SU 20GA 1-1/2IN BREAST
• 50382904094084: NEEDLE BIOPSY S/SU 20GA 2-1/2IN BREAST
• 50382904094077: NEEDLE BIOPSY S/SU 20GA 3-1/2IN BREAST
• 30382903051077: NEEDLE 30GA 1/2IN