FDA.reportPublic FDA data

Ultra-Fine

Primary DI
50383017841855
Brand
Ultra-Fine
Company
Embecta Medical II, LLC
Model
328418
Catalog number
328418
Device description
Ultra-Fine™ Insulin Syringes, U-100, 8mm, 31G, 1mL
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
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00383017841836PackageGS110In Commercial Distribution
50383017841855PackageGS15In Commercial Distribution
00383017841812PrimaryGS10
80383017841887Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00383017841836003830178418363830178418360383017841836
5038301784185550383017841855
00383017841812003830178418123830178418120383017841812
8038301784188780383017841887

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Millimeter
Needle Gauge31Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118777356
Device count
10
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
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
10383017829114Ultra-Fine3282913282912024-11-22
10383017941014embecta Insulin Syringe3294103294102024-11-22
10383017941212embecta Insulin Syringe3294123294122024-11-22
10383017942011embecta Insulin Syringe3294203294202024-11-22
10383017942417embecta Insulin Syringe3294243294242024-11-22
10383017946118embecta Insulin Syringe3294613294612024-11-22
10383017946514embecta Insulin Syringe3294653294652024-11-22
30383017055135Nano 2nd Gen3205513205512024-11-22

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Primary DI, Brand, Company table
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