FDA.reportPublic FDA data

Terumo

Primary DI
26930197851797
Brand
Terumo
Company
Shanghai Kindly Enterprise Development Group Co.,Ltd.
Model
SENG-03L2525R
Device description
Hypodermic Syringe with Safety Needle 3ml 25G×1“
Published
2023-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
K221416000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221416000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26930197851797PackageGS112In Commercial Distribution
16930197851790PrimaryGS10
06930197851793Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2693019785179726930197851797
1693019785179016930197851790
06930197851793069301978517936930197851793

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe/needleA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a non-retractable needle is included, either attached or detached (usually capped for user protection). It is intended for various medical applications and is not dedicated to medication administration. The syringe is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530462431
Device count
100
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
06930197851915TerumoSENG - SS-01L2023-02-28
16930197851738TerumoSENG-01L2516R2023-02-28
16930197851745TerumoSENG-01L2525R2023-02-28
16930197851752TerumoSENG-01L2713R2023-02-28
16930197851776TerumoSENG-03L2325R2023-02-28
16930197851783TerumoSENG-03L2516R2023-02-28
16930197851790TerumoSENG-03L2525R2023-02-28
16930197851806TerumoSENG-03L2538R2023-02-28
16930197851813TerumoSENG-1825R2023-02-28
16930197851820TerumoSENG-1838R2023-02-28
16930197851837TerumoSENG-2238R2023-02-28
16930197851844TerumoSENG-2325R2023-02-28
16930197851851TerumoSENG-2338R2023-02-28
16930197851868TerumoSENG-2516R2023-02-28
16930197851875TerumoSENG-2525R2023-02-28
16930197851882TerumoSENG-2538R2023-02-28
06930197851892TerumoSENG-2713R2023-02-28
06930197851908TerumoSENG-3013R2023-02-28
16930197851899TerumoSENG-2713R2023-02-28
16930197851905TerumoSENG-3013R2023-02-28

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