SURGUARD3

Basic Information

• Brand Name: SURGUARD3
• Primary DI: 34806017508167
• Version / Model: SG3-2238
• Company Name: TERUMO (PHILIPPINES) CORPORATION
• Labeler DUNS: 718848773
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-07
• Public Version: 5
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: ccf150ee-a2cb-40ce-9eb4-46461186f2ff

Device Description

SURGUARD3 Safety Hypodermic Needle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMI	Needle, hypodermic, single lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59230	Hypodermic needle, single-use	A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	54806017508161	GS1	Carton	8	In Commercial Distribution
Primary	34806017508167	GS1
Unit of Use	14806017508163	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K113422	000

Device Sizes

Type	Value	Unit	Text
Length	1.5	Inch
Needle Gauge	22	Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile. Handle with care. Keep dry. Keep away from sunlight. Stacking limit by 3.