FDA.reportPublic FDA data

Overt Insulin Pen Needles

Primary DI
00860010015209
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
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

Contacts#

Phone, Email table
PhoneEmail
1.877.342.2385info@curativediagnostics.com

Regulatory Flags#

DUNS number
180779782
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10860010015206Overt Insulin Pen NeedlesCD-31G660010-0015-202023-03-27
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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