FDA.reportPublic FDA data

REDOX SMART PAN Pen Needle

Primary DI
16972857299252
Brand
REDOX SMART PAN Pen Needle
Company
Sandstone Medical (Suzhou) Inc.
Model
04-3105
Published
2026-09-24
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

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
36972857299256PackageGS120In Commercial Distribution
16972857299252PrimaryGS10
06972857299255Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3697285729925636972857299256
1697285729925216972857299252
06972857299255069728572992556972857299255

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
554500882
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972857295677contour comfort Pen Needle04-32042026-08-19
16972857297784Easydrip Glider5 Classic Pro Pen Needles03-31052026-07-09
16972857297791Easydrip PentaGlider Plus Pro Pen Needles04-32042026-07-09
16972857296350MireMed PEN TIPS02-32042026-04-30
16972857296008Easydrip Pen Needles01-31082025-12-12
36972857296002Easydrip Pen Needles01-31082025-12-12
16972857295186Rapha Pen Needles01-32042025-07-31
16972857295193EveryMeds Pen Needles01-32042025-07-31
36972857295180Rapha Pen Needles01-32042025-07-31
36972857295197EveryMeds Pen Needles01-32042025-07-31
16972857295148Easydrip SafeGard Duo Safety Pen NeedlesHS2025-07-08
36972857295142Easydrip SafeGard Duo Safety Pen NeedlesHS2025-07-08
16972857294738Easydrip Plus Pen Needles02-31082025-05-17
16972857294745Easydrip Plus Pen Needles02-32062025-05-17
36972857294732Easydrip Plus Pen Needles02-31082025-05-17
36972857294749Easydrip Plus Pen Needles02-32062025-05-17
16972857294325Easydrip Pen Needles01-32042025-02-28
36972857294329Easydrip Pen Needles01-32042025-02-28
16972857293854Easydrip Plus Pen Needles 32G×4mm02-32042024-11-11
36972857293858Easydrip Plus Pen Needles 32G×4mm02-32042024-11-11

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MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
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