FDA UDI
In Commercial Distribution
🇺🇸 United States
Susvimo
DI: 00810042590014
·
Model: 0580422
·
Genentech, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Susvimo
- Primary DI
- 00810042590014
- Version / Model
- 0580422
- Catalog Number
- 0580422
- Company Name
- Genentech, Inc.
- Labeler DUNS
- 080129000
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-29
- Public Version
- 4
- Public Version Date
- 2023-11-20
- Public Version Status
- Update
- Public Device Record Key
- f4ad932a-fe04-4114-a7e5-8dda2afd2fec
Device Description
Susvimo Insertion Tool Assembly
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QQQ | Guide And Positioner, Ophthalmic Drug Delivery Device | Ophthalmic | 886.4300 | 1 |
| QIZ | Material, Implantable For Controlled Release, Cder Or Cber Led | Unknown | N |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64482 | Implantable intraocular medication reservoir | A device intended to be surgically implanted in the posterior segment of the eye to contain a therapeutic solution and provide its continuous passive delivery into the vitreous. It consists of a synthetic polymer tubular chamber designed to be periodically refilled with the therapeutic solution through its septum port at the scleral surface, and includes a porous distal end for passive diffusion of the solution into the vitreous; devices associated with implantation are typically provided with the implant. It is typically used to deliver a pharmaceutical agent for treating retinal diseases [e.g., neovascular age-related macular degeneration (nAMD), diabetic retinopathy]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810042590014 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius