BNX N-19-05

GUDID 00855208005056

FINE NEEDLE ASPIRATION NEEDLE

Covidien LP

General-purpose endoscopic needle, single-use

• Primary Device ID: 00855208005056
• NIH Device Record Key: 606cfcaa-1a5c-4853-af81-49ea253b7e5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BNX
• Version Model Number: N-19-05
• Catalog Number: N-19-05
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Needle Gauge: 19 Gauge
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge
• Device Size Text, specify: 0
• Needle Gauge: 19 Gauge

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855208005056 [Primary]
GS1	10855208005053 [Package]; Package: PACK_OR_INNER_PACK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103668

FDA Product Code

• FCG: Biopsy needle

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: 2016-09-24

On-Brand Devices [BNX]

• 00855208005070: FINE NEEDLE ASPIRATION NEEDLE
• 00855208005063: FINE NEEDLE ASPIRATION NEEDLE
• 00855208005056: FINE NEEDLE ASPIRATION NEEDLE
• 00855208005049: FINE NEEDLE ASPIRATION SYSTEM
• 00855208005032: FINE NEEDLE ASPIRATION SYSTEM
• 00855208005025: FINE NEEDLE ASPIRATION SYSTEM
• 00855208005018: FINE NEEDLE ASPIRATION SYSTEM
• 00855208005001: FINE NEEDLE ASPIRATION SYSTEM