FDA.reportPublic FDA data

Wealy

Primary DI
06971603580500
Brand
Wealy
Company
Shantou Wealy Medical Instrument Co., Ltd.
Model
"3ml 25Gx1"""
Device description
Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retracted at the same time. Providing a safe use for healthworkers to minimize the risk of diseases cross-infection.
Published
2021-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K141640000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141640000AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLEShantou Wealy Medical Instrument Co.,Ltd2014-11-19MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971603580531PackageGS1100In Commercial Distribution
06971603580562PackageGS110In Commercial Distribution
06971603580500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971603580531069716035805316971603580531
06971603580562069716035805626971603580562
06971603580500069716035805006971603580500

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringeA sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
545570186
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971603585192Wealy20ml2022-12-13
06971603585222Wealy60ml2022-10-13
06971603585239Wealy60ml2022-10-13
06971603580579Wealy"3ml 25Gx5/8"""2021-04-25
06971603580531Wealy3ml 25Gx1"2021-04-25
06971603580586Wealy3ml 25Gx5/8"2021-04-25
06971603580487Wealy"3ml 23Gx1"""2021-03-20
06971603580517Wealy3ml 23Gx1"2021-03-20
06971603580326Wealy"10ml 22Gx1 1/2"""2020-12-29
06971603580371Wealy10ml 22Gx1 1/2"2020-12-29
06971603580296Wealy"1ml 25Gx1"""2020-12-28
06971603580302Wealy"1ml 25Gx5/8"""2020-12-28
06971603580289Wealy"1ml 27Gx1/2"""2020-12-28
06971603580340Wealy1ml 25Gx1"2020-12-28
06971603580357Wealy1ml 25Gx5/8"2020-12-28
06971603580319Wealy"3ml 23Gx1 1/4"""2020-12-28

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