FDA.reportPublic FDA data

Ultra-Fine

Primary DI
10383017493018
Brand
Ultra-Fine
Company
Embecta Medical II, LLC
Model
324930
Catalog number
324930
Device description
Ultra-Fine™ Insulin Syringes, U-100, 6mm, 31G, 0.3mL, 1/2 unit
Published
2024-11-22
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

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
30383017493036PackageGS110In Commercial Distribution
50383017493054PackageGS15In Commercial Distribution
10383017493018PrimaryGS10
80383017493086Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038301749303630383017493036
5038301749305450383017493054
1038301749301810383017493018
8038301749308680383017493086

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
Length6Millimeter
Needle Gauge31Gauge

Regulatory Flags#

DUNS number
118777356
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01