Susvimo

Primary DI
00810042590014
Company
Genentech, Inc.
Model
10228592
Published
2021-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
00810042590014PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00810042590014PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
QQQGuide And Positioner, Ophthalmic Drug Delivery Device1Ophthalmic886.4300NIneligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Ophthalmic implant handling forceps, single-useA hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. 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
00810042590021Susvimo102144172021-11-29
00810042590038Susvimo102145852021-11-29

Other Devices Sharing Product Codes

No records found.