FDA.reportPublic FDA data

Ultra-Fine

Primary DI
50383017820355
Brand
Ultra-Fine
Company
Embecta Medical II, LLC
Model
328203
Catalog number
328203
Device description
Ultra-Fine™ Pen Needles, 12.7mm, 29G, 3bevel, TW
Published
2024-11-22
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

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
50383017820355PackageGS112In Commercial Distribution
00383017820336PrimaryGS10
80383017820387Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038301782035550383017820355
00383017820336003830178203363830178203360383017820336
8038301782038780383017820387

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
Length12.7Millimeter
Needle Gauge29Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118777356
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10383017593015Ultra-Fine SAFETY3059303059302026-07-21
10383017593213Ultra-Fine SAFETY3059323059322026-07-21
10383017593411Ultra-Fine SAFETY3059343059342026-07-21
10383017593510Ultra-Fine SAFETY3059353059352026-07-21
10383017593718Ultra-Fine SAFETY3059373059372026-07-21
10383017844612Ultra-Fine SAFETY3284463284462026-07-21
10383017844711Ultra-Fine SAFETY3284473284472026-07-21
10383017844919Ultra-Fine SAFETY3284493284492026-07-21
10383017490611Ultra-Fine3249063249062024-11-22
10383017490710Ultra-Fine3249073249072024-11-22
10383017490819Ultra-Fine3249083249082024-11-22
10383017493018Ultra-Fine3249303249302024-11-22
10383017493117Ultra-Fine3249313249312024-11-22
10383017493216Ultra-Fine3249323249322024-11-22
10383017493315Ultra-Fine3249333249332024-11-22
10383017827813Ultra-Fine3282783282782024-11-22
10383017827912Ultra-Fine3282793282792024-11-22
10383017828018Ultra-Fine3282803282802024-11-22
10383017828919Ultra-Fine3282893282892024-11-22
10383017829015Ultra-Fine3282903282902024-11-22

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