FDA.reportPublic FDA data

Surguard™3

Primary DI
05413206222445
Brand
Surguard™3
Company
Terumo Europe NV
Model
SG3-1925RB
Catalog number
SG3-1925RB
Device description
Surguard™3 Safety Hypodermic Needle
Published
2022-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212095000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212095000SurGuard3 Safety Hypodermic NeedleTerumo Europe N.V.2022-08-22FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35413206222446PackageGS1280In Commercial Distribution
55413206222440PackageGS14In Commercial Distribution
05413206222445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3541320622244635413206222446
5541320622244055413206222440
05413206222445054132062224455413206222445

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
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Needle Gauge19Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry.
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
370193559
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05413206050260K-Pack Surshield™KN-S2516RBKN-S2516RB2016-09-05
05413206223640K-Pack IIKN-2713RKT50KN-2713RKT502018-05-07
05413206223688K-Pack IIKN-3013RKT50KN-3013RKT502018-05-07
05413206211418K-Pack IIKN-2719RBTSKN-2719RBTS2016-09-05
05413206346042TerumoKH-2713RBBTCKH-2713RBBTC2025-09-16
05413206346059TerumoKH-2913RBBTCKH-2913RBBTC2025-09-16
05413206346219K-Pack Surshield™KN-S2713RBTKN-S2713RBT2025-09-16
05413206346110K-Pack Embrace™KNAS-2516RBKNAS-2516RB2025-09-15
05413206346127K-Pack Embrace™KNAS-2525RBKNAS-2525RB2025-09-15
55413206346115K-Pack Embrace™KNAS-2516RBKNAS-2516RB2025-09-15
55413206346122K-Pack Embrace™KNAS-2525RBKNAS-2525RB2025-09-15
05413206251223TerumoNF-3013RBKE05MNF-3013RBKE05M2023-10-27
35413206251224TerumoNF-3013RBKE05MNF-3013RBKE05M2023-10-27
05413206050277K-Pack Surshield™KN-S2713RBKN-S2713RB2016-09-05
05413206222452Surguard™3SG3-1938RBSG3-1938RB2022-10-28
05413206222469Surguard™3SG3-2138RBSG3-2138RB2022-10-28
05413206222476Surguard™3SG3-2516RBSG3-2516RB2022-10-28
05413206054923SURFLO™SV-S23FL35SV-S23FL352016-09-05
05413206054947SURFLO™SV-S25FL35SV-S25FL352016-09-05
05413206214914SURFLO™SV-S25FL35CSV-S25FL35C2017-06-21

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