FDA.reportPublic FDA data

SURGUARD2

Primary DI
34806017507115
Brand
SURGUARD2
Company
TERUMO (PHILIPPINES) CORPORATION
Model
SG2+2516
Device description
SURGUARD2 Safety Hypodermic Needle
Published
2017-02-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEGSYRINGE, ANTISTICK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051865000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051865000TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILARTerumo Medical Corp.2005-09-27MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34806017507115PackageGS1100In Commercial Distribution
54806017507119PackageGS18In Commercial Distribution
14806017507111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3480601750711534806017507115
5480601750711954806017507119
1480601750711114806017507111

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.63Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile. Handle with care. Keep dry. Keep away from sunlight. Stacking limit by 4.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
718848773
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
34806017510146SURFLOSR-OX1451CA2016-09-14
34806017510153SURFLOSR-OX1632CA2016-09-14
34806017510160SURFLOSR-OX1651CA2016-09-14
34806017510177SURFLOSR-OX1664CA2016-09-14
34806017510184SURFLOSR-OX1851CA2016-09-14
34806017510191SURFLOSR-OX1864CA2016-09-14
34806017512225SURFLOSR-OX1464CA2016-09-14
34806017512232SURFLOSR-OX1832CA2016-09-14
34806017512249SURFLOSR-OX2051CA2016-09-14
34806017512256SURFLOSR-OX2032CA2016-09-14
34806017512263SURFLOSR-OX2025CA2016-09-14
34806017512270SURFLOSR-OX2225CA2016-09-14
34806017512287SURFLOSR-OX2419CA2016-09-14
14806017506992SURGUARD2SG2+18252017-02-06
14806017507005SURGUARD2SG2+18382017-02-28
14806017507012SURGUARD2SG2+19252017-02-28
14806017507029SURGUARD2SG2+19382017-02-28
14806017507036SURGUARD2SG2+20252017-02-28
14806017507043SURGUARD2SG2+20382017-02-28
14806017507050SURGUARD2SG2+21252017-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056999020248SurTract™RONCADELLE OPERATIONS SRLMEG2026-05-31
08056999020255SurTract™RONCADELLE OPERATIONS SRLMEG2026-05-31
08056999020262SurTract™RONCADELLE OPERATIONS SRLMEG2026-05-31
10840330704868ProCureTwin Med, LLCMEG2026-05-27
10840330704875ProCureTwin Med, LLCMEG2026-05-27
10840330705544ProCureTwin Med, LLCMEG2026-05-27
10840330705551ProCureTwin Med, LLCMEG2026-05-27
10840330705568ProCureTwin Med, LLCMEG2026-05-27
08800052609204"SHINA SAFETY SYRINGE 1.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609211"SHINA SAFETY SYRINGE 1.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609228"SHINA SAFETY SYRINGE 3.0cc 23G x 1"""SHINA MED CORPORATIONMEG2026-03-25
08800052609235"SHINA SAFETY SYRINGE 3.0cc 25G x 1"""SHINA MED CORPORATIONMEG2026-03-25
09347144013093Metier MedicalMETIER MEDICAL LTDMEG2025-07-08
10850053289627SURGYCOSurgyco LLCMEG2024-08-09
10850053289634SURGYCOSurgyco LLCMEG2024-08-09
10850053289641SURGYCOSurgyco LLCMEG2024-08-09
10850053289665SURGYCOSurgyco LLCMEG2024-08-09
10885380184703MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184987MonojectCardinal Health 200, LLCMEG2024-03-26
10885380184994MonojectCardinal Health 200, LLCMEG2024-03-26
10193489037869MedlineMEDLINE INDUSTRIES, INC.MEG2024-02-01
10612479268705McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
10612479268736McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2023-11-27
10193489037814MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037821MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037838MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037845MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037852MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037890MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10
10193489037906MedlineMEDLINE INDUSTRIES, INC.MEG2023-11-10