FDA.reportPublic FDA data

NOVOFINE PLUS 29G

Primary DI
00301691863012
Brand
NOVOFINE PLUS 29G
Company
NOVO NORDISK INC.
Model
186301
Catalog number
186301
Device description
NovoFine® Plus is a sterile single use needle for subcutaneous injection of drugs with a pen injector device.
Published
2026-07-31
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

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
K231255000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231255000NovoFine® PlusNovo Nordisk, Inc.2023-08-25FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30301691863013PackageGS11In Commercial Distribution
00301691863012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3030169186301330301691863013
00301691863012003016918630123016918630120301691863012

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
Length0
Needle Gauge0

Contacts#

Phone, Email table
PhoneEmail
+18007276500nnicustomercare@novonordisk.com

Regulatory Flags#

DUNS number
012177531
Device count
1
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00301691853891NovoTwist® 32G1853891853892016-09-17

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