FDA.reportPublic FDA data

Safety Needle

Primary DI
05907527942002
Brand
Safety Needle
Company
STERIPACK MEDICAL POLAND SP Z O O
Model
7527942002
Published
2024-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
05907527942002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05907527942002059075279420025907527942002

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

Regulatory Flags#

DUNS number
522155365
Device count
1
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
05907527942019Safety Needle 75279420192024-02-27
05907527942064Safety Needle 75279420642024-02-27
05907527942071Safety Needle 75279420712024-02-27
05907527942187Safety Needle 75279421872024-02-27
05907527942026Safety NeedleSafety Needle 23Gx12018-10-22
05907527942033Safety NeedleSafety Needle 22Gx1 1/22018-10-22
05907527942088Safety NeedleSafety Needle 22Gx12018-10-22
05907527942095Safety NeedleSafety Needle 22Gx1 1/22018-10-22
05907527942194Safety NeedleSafety Needle 20Gx1 1/22018-10-22

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Primary DI, Brand, Company table
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