FDA.report

SecureSafe Safety Pen Needle

Primary DI
00616784965635
Brand
SecureSafe Safety Pen Needle
Company
DYNAREX CORPORATION
Model
9656
Device description
SecureSafe Safety Pen Needle, 30G- 8mm, 30Gx 5/16"
Published
2021-09-01
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

Related Records

Product Codes

CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784965635PackageGS112In Commercial Distribution
00616784965628PrimaryGS10
00616784965611Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784965635006167849656356167849656350616784965635
00616784965628006167849656286167849656280616784965628
00616784965611006167849656116167849656110616784965611

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

Regulatory Flags

DUNS number
008124539
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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