FDA.reportPublic FDA data

SUSVIMO

Primary DI
00810042590045
Brand
SUSVIMO
Company
Genentech, Inc.
Model
4000100
Catalog number
4000100
Device description
SUSVIMO REFILL NEEDLE
Published
2024-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00810042590045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810042590045008100425900458100425900450810042590045

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic needle, single-useA slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080129000
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810042590052SUSVIMO400012040001202024-07-01
00810042590007Susvimo058042105804212021-11-29
00810042590014Susvimo058042205804222021-11-29
00810042590038Susvimo058042405804242021-11-29
00810042590021Susvimo058042305804232021-11-29

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00810011730816QikDiagTianjin Huahong Technology Co., Ltd.FMI2026-07-10
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20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
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