FDA.report

droplet® pen needle

Primary DI
05907996095322
Brand
droplet® pen needle
Company
HTL STREFA S A
Model
32G x 8mm
Catalog number
9083
Device description
110 pcs sterile single use droplet® pen needles per box, intended to be used with a pen injector device for the subcutaneous injection of insulin.
Published
2018-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15907996095329PackageGS110In Commercial Distribution
25907996095326PackageGS14In Commercial Distribution
05907996095322PrimaryGS10
85907996095328Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1590799609532915907996095329
2590799609532625907996095326
05907996095322059079960953225907996095322
8590799609532885907996095328

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+48422700010info@htl-strefa.com

Regulatory Flags

DUNS number
422528088
Device count
110
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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10859135002598Droplet® insulin syringe 1ml, 31 x 6mm62212025-02-20
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