FDA.reportPublic FDA data

Susvimo

Primary DI
00810042590038
Brand
Susvimo
Company
Genentech, Inc.
Model
0580424
Catalog number
0580424
Device description
Susvimo Explant Tool
Published
2021-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810042590038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810042590038008100425900388100425900380810042590038

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-835-2555xx@xx.xx

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810042590045SUSVIMO400010040001002024-07-01
00810042590052SUSVIMO400012040001202024-07-01
00810042590007Susvimo058042105804212021-11-29
00810042590014Susvimo058042205804222021-11-29
00810042590021Susvimo058042305804232021-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G223M111991S0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-10-01
00190776432942MillenniumAvalign Technologies, Inc.HNR2026-09-30
00724995317973V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318024V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318246V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318253V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318284V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318307V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318338V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318345V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318451V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318468V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318475V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318482V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318499V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318598V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318673V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318680V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318697V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318703V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318741V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318772V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318833V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318857V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318932V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318949V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995317980V. MuellerSteris CorporationHNR2026-09-24
00724995318321V. MuellerSteris CorporationHNR2026-09-24
00724995318413V. MuellerSteris CorporationHNR2026-09-24
00724995318420V. MuellerSteris CorporationHNR2026-09-24