SURGUARD2

GUDID 54806017507003

SURGUARD2 Safety Hypodermic Needle

TERUMO (PHILIPPINES) CORPORATION

Hypodermic needle, single-use

• Primary Device ID: 54806017507003
• NIH Device Record Key: 76e5ecb9-6b50-4dfb-b390-3cc214187a48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGUARD2
• Version Model Number: SG2+1838
• Company DUNS: 718848773
• Company Name: TERUMO (PHILIPPINES) CORPORATION
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com
• Phone: +1(800)283-7866
• Email: tmccustomer.admin@terumomedical.com

Device Dimensions

• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Handle with care. Keep dry. Keep away from sunlight. Stacking limit by 4.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Handle with care. Keep dry. Keep away from sunlight. Stacking limit by 4.

Device Identifiers

Device Issuing Agency	Device ID
GS1	14806017507005 [Primary]
GS1	34806017507009 [Package]; Contains: 14806017507005; Package: Shelfbox [100 Units]; In Commercial Distribution
GS1	54806017507003 [Package]; Contains: 34806017507009; Package: Carton [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051865

FDA Product Code

• MEG: SYRINGE, ANTISTICK

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-02-28

On-Brand Devices [SURGUARD2]

• 54806017512946: SURGUARD2 Safety Hypodermic Needle
• 54806017512632: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017512625: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506952: SURGUARD2 Safety Hypodermic Needle
• 54806017506709: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506693: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506686: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506679: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506662: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506655: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506648: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506631: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506624: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506617: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506600: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506594: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506587: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506570: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506563: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506556: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506549: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506532: SURGUARD2 Hypodermic Syringe with Safety Needle
• 54806017506525: SURGUARD2 Safety Hypodermic Needle
• 54806017506518: SURGUARD2 Safety Hypodermic Needle
• 54806017506501: SURGUARD2 Safety Hypodermic Needle
• 54806017506495: SURGUARD2 Safety Hypodermic Needle
• 54806017506488: SURGUARD2 Safety Hypodermic Needle
• 54806017506471: SURGUARD2 Safety Hypodermic Needle
• 54806017506464: SURGUARD2 Safety Hypodermic Needle
• 54806017506457: SURGUARD2 Safety Hypodermic Needle
• 54806017506440: SURGUARD2 Safety Hypodermic Needle
• 54806017506433: SURGUARD2 Safety Hypodermic Needle
• 54806017506426: SURGUARD2 Safety Hypodermic Needle
• 54806017506419: SURGUARD2 Safety Hypodermic Needle
• 54806017506402: SURGUARD2 Safety Hypodermic Needle
• 54806017506396: SURGUARD2 Safety Hypodermic Needle
• 54806017506389: SURGUARD2 Safety Hypodermic Needle
• 34806017506378: SURGUARD2 Safety Hypodermic Needle
• 54806017506365: SURGUARD2 Safety Hypodermic Needle
• 54806017506358: SURGUARD2 Safety Hypodermic Needle
• 34806017507177: SURGUARD2 Safety Hypodermic Needle
• 54806017507164: SURGUARD2 Safety Hypodermic Needle
• 54806017507157: SURGUARD2 Safety Hypodermic Needle
• 34806017507146: SURGUARD2 Safety Hypodermic Needle
• 34806017507139: SURGUARD2 Safety Hypodermic Needle
• 34806017507122: SURGUARD2 Safety Hypodermic Needle
• 34806017507115: SURGUARD2 Safety Hypodermic Needle
• 34806017507108: SURGUARD2 Safety Hypodermic Needle
• 54806017507096: SURGUARD2 Safety Hypodermic Needle
• 34806017507085: SURGUARD2 Safety Hypodermic Needle