FDA.reportPublic FDA data

ACU-NEEDLE

Primary DI
10814105020347
Brand
ACU-NEEDLE
Company
ACUDERM, INC.
Model
NP2010
Device description
"20 standard gauge 1"" needle, high quality economical plastic hub hypodermic needles. Fits both luer slip and luer lock syringes, tri-beveled tip. Sterile"
Published
2020-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

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
K874024000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K874024000ACU-MICRO-NEEDLEAcuderm, Inc.1987-11-23FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10814105020347PrimaryGS10
00814105020340Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081410502034710814105020347
00814105020340008141050203408141050203400814105020340

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
954-733-6935cust-service@acuderm.com

Regulatory Flags#

DUNS number
071426803
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814105020005Acu-Dispo-CuretteR012020-09-22
00814105020012Acu-Dispo-CuretteR022020-09-22
00814105020029Acu-Dispo-CuretteR032020-09-22
00814105020036Acu-Dispo-CuretteR042020-09-22
00814105020043Acu-Dispo-CuretteR052020-09-22
00814105020050Acu-Dispo-CuretteR072020-09-22
00814105021316Acu-Dispo-CuretteRCOM2020-09-22
00814105021323Acu-Dispo-CuretteRCOMPL2020-09-22
00814105020876ACU-GUARD0ADG51S2020-01-03
10814105020873ACU-GUARDADG51S2020-01-03
10814105021108Acu-ScissorsSCS2020-09-22
10814105021115Acu-ScissorsSCC2020-09-22
10814105021207ACU-DTMM1012020-09-22
10814105021214ACU-DTMM1012020-09-22
10814105021221ACU-SABOURAUDM1032020-09-22
10814105021238ACU-NICKERSONM1042020-09-22
00814105020883Acu-PunchP12020-09-22
00814105020890Acu-PunchP1.52020-09-22
00814105020906Acu-PunchP22020-09-22
00814105020913Acu-PunchP2.52020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
08056999020279SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020286SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020316SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
00840464800019Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27