Orbit Subretinal Delivery System
- Primary DI
- 00850009362001
- Brand
- Orbit Subretinal Delivery System
- Company
- Gyroscope Usa, Inc.
- Model
- PN1008904-001
- Device description
- Subretinal Injection Device Set
- Published
- 2020-09-29
- 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
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00850009362001 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00850009362001 | 00850009362001 | 850009362001 | 0850009362001 |
GMDN Terms
| Term | Definition |
|---|
| Ophthalmic surgical procedure kit, non-medicated, single-use | A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device. |
Regulatory Flags
- DUNS number
- 071418804
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- 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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00850009362018 | Orbit Subretinal Delivery System | PN1008919-001 | | 2020-09-29 |
| 00850009362025 | Orbit Subretinal Delivery System | PN1008927-001 | | 2020-09-29 |
| 00850009362032 | Orbit Subretinal Delivery System | PN1008946-001 | | 2020-09-29 |