FDA.reportPublic FDA data

Hypodermic Needle 18Gx1"

Primary DI
10850014433366
Brand
Hypodermic Needle 18Gx1"
Company
DISTRIBUTION UNLIMITED, LLC
Model
1
Catalog number
DU2553
Device description
the needle is a hollow needle commonly used with a syringe to inject substances into the body or extract fluids from it.
Published
2020-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850014433366PackageGS1100In Commercial Distribution
20850014433363PackageGS110In Commercial Distribution
00850014433369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001443336610850014433366
2085001443336320850014433363
00850014433369008500144333698500144333690850014433369

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge18Gauge
Shaft Length1Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
926603486
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
00850014433253Syringe 3ml w/o Needle1DU25032020-08-06
00850014433260Syringe 5ml w/o Needle1DU25052020-08-06
00850014433284Syringe 10ml w/o Needle1DU25102020-08-06
00850014433642Universal Block Procedure Trays1DU36402020-08-19
00850014433161Grounding Pads1DU21002020-08-13
00850014433130"IV Extension Set 6"" "1DU22602020-08-19
00850014433222"Tourniquet 1""x18"""1DU22102020-08-06
00850014433215ETCO2 Nasal Cannula1DU10902020-08-13
00850014433505"Cohesive bandage 2""x5yds stretched"1DU35502020-08-06
10850014433137IV Extension Set 6" 1DU22602020-08-19
20850014433646Universal Block Procedure Trays1DU36402020-08-19
00850014433239Sterile Specimen Cup with Temp Strip1DU31002020-08-13
00850014433154Nasal Oxygen Cannula1DU10102020-08-13
10850014433168Grounding Pads1DU21002020-08-13
20850014433219ETCO2 Nasal Cannula1DU10902020-08-13
10850014433236Sterile Specimen Cup with Temp Strip1DU31002020-08-13
00850014433109Anesthesia Mask (Large) 1DU10782020-08-06
00850014433123Anesthesia Mask (Medium) 1DU10732020-08-06
00850014433178"Ice Compress 4""x7"""1DU17032020-08-06
00850014433246Non Woven Sponge 2x2 4 ply 1DU12022020-08-06

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Primary DI, Brand, Company table
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00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
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