K-Pack Surshield™ KN-S2516RB

GUDID 55413206050265

K-Pack Surshield™ Needle

Terumo Europe NV

Hypodermic needle, single-use

• Primary Device ID: 55413206050265
• NIH Device Record Key: c69da97a-c36c-4247-8200-8fddd2ace718
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Pack Surshield™
• Version Model Number: KN-S2516RB
• Catalog Number: KN-S2516RB
• Company DUNS: 370193559
• Company Name: Terumo Europe NV
• 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(800)283-7866
• Email: tmccustomer.admin@terumomedical.com

Device Dimensions

• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not store at extreme temperature and humidity.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05413206050260 [Primary]
GS1	55413206050265 [Package]; Contains: 05413206050260; Package: Carton [1500 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110527

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-05

On-Brand Devices [K-Pack Surshield™]

• 55413206050272: K-Pack Surshield™ Needle
• 55413206050265: K-Pack Surshield™ Needle