FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 10818255011026
·
Model: N/A
·
MICROVISION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 10818255011026
- Version / Model
- N/A
- Catalog Number
- 5243
- Company Name
- MICROVISION, INC.
- Labeler DUNS
- 013486803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-04
- Public Version
- 3
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- ce515018-c38c-44d7-95f2-58865446c7cf
Device Description
Disposable Two-Step Trocar System, 23Ga. (3 Trocar Cannula Inserters with Pre-Loaded Self-Sealing Trocar Cannula & 1 Infusion Line)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NGY | Cannula, Trocar, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46840 | Ophthalmic cannulation set, single-use | A collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30818255011020 | GS1 | carton | 5 | In Commercial Distribution | |
| Primary | 10818255011026 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.655 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- caution
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep away from direct sunlight