SURGUARD3

GUDID 54806017510706

SURGUARD3 Safety Hypodermic Needle

TERUMO (PHILIPPINES) CORPORATION

Hypodermic needle, single-use

• Primary Device ID: 54806017510706
• NIH Device Record Key: 42f93cb2-7e94-47bc-a31f-535d40c2e9f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGUARD3
• Version Model Number: SG3+1816
• 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 3.
• Special Storage Condition, Specify: Between 0 and 0 *Fragile. Handle with care. Keep dry. Keep away from sunlight. Stacking limit by 3.

Device Identifiers

Device Issuing Agency	Device ID
GS1	14806017510708 [Primary]
GS1	34806017510702 [Package]; Contains: 14806017510708; Package: Shelfbox [100 Units]; In Commercial Distribution
GS1	54806017510706 [Package]; Contains: 34806017510702; Package: Carton [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152362

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: 6
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-02-14

On-Brand Devices [SURGUARD3]

• 54806017511826: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017511819: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017511802: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017511796: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017511789: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017511772: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017511765: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508529: SURGUARD3 Safety Hypodermic Needle
• 54806017508512: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508505: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508499: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508482: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508475: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508468: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508451: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508444: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508437: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508420: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508413: SURGUARD3 Hypodermic Syringe with Safety Needle
• 54806017508253: SURGUARD3 Safety Hypodermic Needle
• 54806017508246: SURGUARD3 Safety Hypodermic Needle
• 54806017508239: SURGUARD3 Safety Hypodermic Needle
• 54806017508222: SURGUARD3 Safety Hypodermic Needle
• 54806017508215: SURGUARD3 Safety Hypodermic Needle
• 54806017508208: SURGUARD3 Safety Hypodermic Needle
• 54806017508192: SURGUARD3 Safety Hypodermic Needle
• 54806017508185: SURGUARD3 Safety Hypodermic Needle
• 54806017508178: SURGUARD3 Safety Hypodermic Needle
• 54806017508161: SURGUARD3 Safety Hypodermic Needle
• 54806017508154: SURGUARD3 Safety Hypodermic Needle
• 54806017508147: SURGUARD3 Safety Hypodermic Needle
• 54806017508130: SURGUARD3 Safety Hypodermic Needle
• 54806017508123: SURGUARD3 Safety Hypodermic Needle
• 54806017508116: SURGUARD3 Safety Hypodermic Needle
• 54806017508109: SURGUARD3 Safety Hypodermic Needle
• 54806017508093: SURGUARD3 Safety Hypodermic Needle
• 54806017508086: SURGUARD3 Safety Hypodermic Needle
• 54806017508079: SURGUARD3 Safety Hypodermic Needle
• 34806017510757: SURGUARD3 Safety Hypodermic Needle
• 54806017510744: SURGUARD3 Safety Hypodermic Needle
• 34806017510733: SURGUARD3 Safety Hypodermic Needle
• 34806017510726: SURGUARD3 Safety Hypodermic Needle
• 54806017510713: SURGUARD3 Safety Hypodermic Needle
• 54806017510706: SURGUARD3 Safety Hypodermic Needle
• 54806017509731: SURGUARD3 Safety Hypodermic Needle
• 34806017509720: SURGUARD3 Safety Hypodermic Needle
• 34806017509713: SURGUARD3 Safety Hypodermic Needle
• 34806017509706: SURGUARD3 Safety Hypodermic Needle
• 54806017509694: SURGUARD3 Safety Hypodermic Needle
• 34806017509683: SURGUARD3 Safety Hypodermic Needle