SharkCore C-25-05

GUDID 00855208005117

Fine Needle Biopsy Needle

Covidien LP

General-purpose endoscopic needle, single-use

• Primary Device ID: 00855208005117
• NIH Device Record Key: c20e96ee-6068-4143-8c8d-33e347f02520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SharkCore
• Version Model Number: C-25-05
• Catalog Number: C-25-05
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855208005117 [Primary]
GS1	10855208005114 [Package]; Package: Pack [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141894

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: 2017-09-08

On-Brand Devices [SharkCore]

• 00855208005131: Fine Needle Biopsy System
• 00855208005124: Fine Needle Biopsy Needle
• 00855208005117: Fine Needle Biopsy Needle
• 00855208005100: Fine Needle Biopsy Needle
• 00855208005094: Fine Needle Biopsy System
• 00855208005087: Fine Needle Biopsy System