FDA.reportPublic FDA data

UltraFlo Insulin Pen Needle

Primary DI
B7443357761
Brand
UltraFlo Insulin Pen Needle
Company
QUALITY MEDICAL PRODUCTS USA, INC.
Model
335776
Device description
"33G x 5/32"" (4mm)"
Published
2019-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
B7443357762PackageHIBCC12In Commercial Distribution
B7443357763PackageHIBCC4In Commercial Distribution
B7443357761PrimaryHIBCC0
B7443357760Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Regulatory Flags#

DUNS number
054180248
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B7442259311UltraFlo Insulin Syringe2259312019-06-24
B7442259321UltraFlo Insulin Syringe2259322019-06-24
B7442259331UltraFlo Insulin Syringe2259332019-06-24
B7442259341UltraFlo Insulin Syringe2259342019-06-24
B7442259351UltraFlo Insulin Syringe2259352019-06-24
B7442259361UltraFlo Insulin Syringe2259362019-06-24
B7442259371UltraFlo Insulin Syringe2259372019-06-24
B7442259381UltraFlo Insulin Syringe2259382019-06-24
B7442259391UltraFlo Insulin Syringe2259392019-06-24
B7442259401UltraFlo Insulin Syringe2259402019-06-24
B7442259411UltraFlo Insulin Syringe2259412019-06-24
B7442259421UltraFlo Insulin Syringe2259422019-06-24
B7442259431UltraFlo Insulin Syringe2259432019-06-24
B7442259441UltraFlo Insulin Syringe2259442019-06-24
B7442259451UltraFlo Insulin Syringe2259452019-06-24
B7443357711UltraFlo Insulin Pen Needle3357712019-06-24
B7443357721UltraFlo Insulin Pen Needle3357722019-06-24
B7443357731UltraFlo Insulin Pen Needle3357732019-06-24
B7443357741UltraFlo Insulin Pen Needle3357742019-06-24
B7442259313UltraFlo Insulin Syringe2259312019-06-24

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Primary DI, Brand, Company table
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08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
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