FDA.reportPublic FDA data

SurTract™

Primary DI
08056999020248
Brand
SurTract™
Company
RONCADELLE OPERATIONS SRL
Model
Syringe 1ml
Catalog number
STR-01SS
Device description
Automatically Retractable Safety Syringe intended to provide a safe, accurate and reliable method for the aspiration of fluids or for the injection of fluids immediately after filling.
Published
2026-05-31
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
FMFSyringe, Piston
MEGSyringe, Antistick

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2
MEGSyringe, AntistickGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221981000SafeR Syringe and SafeR StingRoncadelle Operations Srl2022-12-29MEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056999020245PackageGS1100In Commercial Distribution
08056999020248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805699902024518056999020245
08056999020248080569990202488056999020248

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.

Regulatory Flags#

DUNS number
440653185
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
08056999020255SurTract™Syringe 3mlSTR-03SS2026-05-31
08056999020262SurTract™Syringe 5mlSTR-05SS2026-05-31
08056999020279SurTract™Sting 20Gx25mmSTR-2025NN2026-05-31
08056999020286SurTract™Sting 20Gx38mmSTR-2038NN2026-05-31
08056999020293SurTract™Sting 21Gx25mmSTR-2125NN2026-05-31
08056999020309SurTract™Sting 21Gx38mmSTR-2138NN2026-05-31
08056999020316SurTract™Sting 22Gx25mmSTR-2225NN2026-05-31
08056999020323SurTract™Sting 22Gx38mmSTR-2238NN2026-05-31
08056999020330SurTract™Sting 23Gx25mmSTR-2325NN2026-05-31
08056999020347SurTract™Sting 23Gx38mmSTR-2338NN2026-05-31
08056999020354SurTract™Sting 25Gx16mmSTR-2516NN2026-05-31
08056999020361SurTract™Sting 25Gx25mmSTR-2525NN2026-05-31
08056999020385SurTract™Sting 27Gx13mmSTR-2713NN2026-05-31
08056999020408SurTract™Sting 18Gx32mmSTR-1832BN2026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09347144013062Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144013123Metier MedicalMETIER MEDICAL LTDFMF2026-10-19
09347144010009Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010030Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010092Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144010122Metier MedicalMETIER MEDICAL LTDMEG2026-10-17
09347144015004Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016186Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
09347144016216Metier MedicalMETIER MEDICAL LTDFMF2026-10-12
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288496McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
20612479288557McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
20612479288588McKessonMCKESSON MEDICAL-SURGICAL INC.MEG2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193867Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193898Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194109Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194116Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194208Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194215Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194222Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194239Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194246Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194253Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040194260Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05