FDA.report

Susvimo

Primary DI
00810042590021
Company
Genentech, Inc.
Model
10214417
Published
2021-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
080129000
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00810042590021PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00810042590021PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FMINeedle, Hypodermic, Single Lumen2General Hospital880.5570NIneligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-888-835-2555xx@xx.xx

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810042590045SUSVIMO400010040001002024-07-01
00810042590052SUSVIMO400012040001202024-07-01
00810042590007Susvimo102145822021-11-29
00810042590014Susvimo102285922021-11-29
00810042590038Susvimo102145852021-11-29

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