FDA.reportPublic FDA data

Hypodermic Needle, Non-Safety, 20G, 3/4" needles

Primary DI
00840117352339
Brand
Hypodermic Needle, Non-Safety, 20G, 3/4" needles
Company
Dynarex Corporation
Model
6980
Published
2019-05-06
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117352346PackageGS110In Commercial Distribution
00840117352339PrimaryGS10
00810180846684Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117352346008401173523468401173523460840117352346
00840117352339008401173523398401173523390840117352339
00810180846684008101808466848101808466840810180846684

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
008124539
Device count
100
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
true
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
00616784910017CurPro Nylon Suture, Black Monofilament, Nonabsorbable, Synthetic91002016-09-24
00616784910116CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91012016-09-24
00616784910215CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91022016-09-24
00616784910314CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91032016-09-24
00616784910413CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91042016-09-24
00616784910611CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91062016-09-24
00616784910710CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91072016-09-24
00616784913018Polyglycolic Acid (PGA) Sutures, Coated Synthetic Absorbable, Violet, Braided91302016-09-24
00616784913117CurPro Polyglycolic Acid (PGA) Sutures, Coated Synthetic Absorbable, Violet91312016-09-24
00616784914213CurPro Silk Sutures Natural Material, Braided Black, Nonabsorbable91422016-09-24
00616784914312CurPro Silk Sutures Natural Material, Braided Black, Nonabsorbable91432016-09-24
00840117325920Bari + Max Bariatric Steel Crutches, Tall Adult, 1000 lb. weight capacity,101052023-01-11
00840117325937Bari + Max Bariatric Steel Crutches, Adult, 1000 lb. Weight Capacity, 1 Pair101062023-01-11
00616784010113Aluminum Crutches - Youth101012019-09-30
00616784010212Aluminum Crutches - Adult101022019-09-30
00616784010311Aluminum Crutches - Tall101032019-09-30
00616784010410DMECARE Solutions, Universal Crutches101042019-09-26
00840117352124AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67212019-11-25
00840117352148AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67222019-11-25
00840117352162AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67232019-11-25

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