FDA.reportPublic FDA data

Overt Insulin Pen Needles

Primary DI
10860010015206
Brand
Overt Insulin Pen Needles
Company
Curative Diagnostics
Model
CD-31G6
Catalog number
60010-0015-20
Device description
Insulin Pen Needle 6mm length and 31 gauge
Published
2023-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
10860010015206PackageGS130In Commercial Distribution
00860010015209PrimaryGS10
20860010015203Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001001520610860010015206
00860010015209008600100152098600100152090860010015209
2086001001520320860010015203

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Millimeter
Needle Gauge31Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.877.342.2385info@curativediagnostics.com

Regulatory Flags#

DUNS number
180779782
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860010015209Overt Insulin Pen NeedlesCD-31G660010-0015-202023-03-27
00860010015216Overt Insulin Pen NeedlesCD-31G560010-0015-212023-03-27
00860010015223Overt Insulin Pen NeedlesCD-31G860010-0015-222023-03-27
00860010015230Overt Insulin Pen NeedlesCD-32G460010-0015-232023-03-27
10860010015213Overt Insulin Pen NeedlesCD-31G560010-0015-212023-03-27
10860010015220Overt Insulin Pen NeedlesCD-31G860010-0015-222023-03-27
10860010015237Overt Insulin Pen NeedlesCD-32G460010-0015-232023-03-27

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Primary DI, Brand, Company table
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MHC18290272EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18310472EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18313672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18320872EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
MHC18323672EasyTouchMHC MEDICAL PRODUCTS, LLCFMI2026-09-22
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