FDA.reportPublic FDA data

SurTract™

Primary DI
08056999020385
Brand
SurTract™
Company
RONCADELLE OPERATIONS SRL
Model
Sting 27Gx13mm
Catalog number
STR-2713NN
Device description
Automatically Retractable Safety Needle 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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral 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
18056999020382PackageGS1100In Commercial Distribution
28056999020389PackageGS110In Commercial Distribution
08056999020385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805699902038218056999020382
2805699902038928056999020389
08056999020385080569990203858056999020385

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.

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
08056999020248SurTract™Syringe 1mlSTR-01SS2026-05-31
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
08056999020408SurTract™Sting 18Gx32mmSTR-1832BN2026-05-31

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