FDA.reportPublic FDA data

Wealy® RELI®

Primary DI
20386120009289
Brand
Wealy® RELI®
Company
MYCO MEDICAL SUPPLIES INC.
Model
SS5ML23G101
Catalog number
SS5ML23G101
Device description
Retractable Safety Syringe 5ML 23G X 1"
Published
2019-02-15
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
K113587000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113587000AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)Shantou Wealy Medical Instrument Co.,Ltd2012-02-24MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10386120009282PackageGS1100In Commercial Distribution
20386120009289PackageGS110In Commercial Distribution
00386120009285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038612000928210386120009282
2038612000928920386120009289
00386120009285003861200092853861200092850386120009285

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge23Gauge
Total Volume5Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
879187821
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
00386120015088RELI®SST-35W2026-10-01
00386120005669RELIPT7773-SI2015-10-24
00386120006314RELIPT1001-SI2016-04-15
00386120006321RELIPT1002-SI2016-04-15
00386120007854RELIPT556-PPT556-P2017-10-18
00386120008196RELI®PT556-MPT556-M2019-05-13
00386120009735RELI®PT1001-MPT1001-M2019-05-13
00386120009742RELI®PT1002-MPT1002-M2019-05-13
00386120009773RELI®PT7773-MPT7773-M2019-05-13
00386120014227RELI®SBCS21G-122026-02-02
00386120014234RELI®SBCS23G-122026-02-02
00386120014241RELI®SBCS25G-122026-02-02
10386120014224RELI®SBCS21G-122026-02-02
10386120014231RELI®SBCS23G-122026-02-02
10386120014248RELI®SBCS25G-122026-02-02
00386120014128RELISBCN-R20G1012025-11-21
00386120014135RELISBCN-R20G1142025-11-21
00386120014142RELISBCN-R20G1512025-11-21
00386120014159RELISBCN-R21G1012025-11-21
00386120014166RELISBCN-R21G1142025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09347144010009Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010030Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010092Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010122Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288557McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288588McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCMEG2026-07-21
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
10193489037869MedlineMEDLINE INDUSTRIES, INC.MEG2024-02-01