FDA.reportPublic FDA data

NovoTwist® 32G

Primary DI
00301691853891
Brand
NovoTwist® 32G
Company
NOVO NORDISK INC.
Model
185389
Catalog number
185389
Device description
NovoTwist® 32G is a single use disposable injection needle intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide, and somatropin.
Published
2016-09-17
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093109000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093109000NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')Novo Nordisk, Inc.2010-06-18FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30301691853892PackageGS160In Commercial Distribution
00301691853891PrimaryGS10
05712249050054Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030169185389230301691853892
00301691853891003016918538913016918538910301691853891
05712249050054057122490500545712249050054

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
Length5Millimeter
Needle Gauge32Gauge

Contacts#

Phone, Email table
PhoneEmail
1-800-727-6500nnicustomercare@novonordisk.com

Regulatory Flags#

DUNS number
012177531
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00301691863012NOVOFINE PLUS 29G1863011863012026-07-31
00301691863500NOVOFINE PLUS 29G1863501863502026-07-31
00301691863906NovoFine® Plus 29G1863901863902026-07-31
00301691851897NovoFine® 32G Tip1851891851892016-09-17
00301691851972NovoFine® 32G Tip1851971851972016-09-17
00301691852757NovoFine® Autocover® 30G1852751852752016-09-17
00301691854591NovoPen Echo®1854591854592016-11-23
00301691855505NovoFine® Plus 32G1855501855502016-09-17
00301691855918NovoFine® Plus 32G1855911855912016-09-17
00301691856502NovoFine® Plus 32G1856501856502017-12-06
00301691856519NovoFine® Plus 32G1856511856512017-12-06
00301691858506NovoFine® Plus 32G1858501858502017-12-06
00301691858513NovoFine® Plus 32G1858511858512017-12-06
00301697200064Administration Set7200067200062017-06-13
00301697712901FlexPro® PenMate®7712907712902019-08-08
00301691852979NovoFine® Autocover® 30G1852971852972016-09-17
00301691852504NovoFine® 30G1852501852502016-09-17
30301691851898NovoFine® 32G Tip1851891851892016-09-17
30301691851973NovoFine® 32G Tip1851971851972016-09-17
30301691854592NovoPen Echo®1854591854592016-11-23

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