FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10818255010043
·
Model: NA
·
MICROVISION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 10818255010043
- Version / Model
- NA
- Catalog Number
- 5005
- Company Name
- MICROVISION, INC.
- Labeler DUNS
- 013486803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-17
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 130022d3-2c83-40bb-8840-d06a977322a4
Device Description
Low Turbulence Small Incision Phaco Needle Pack 20Ga, 30° Includes: Infusion Sleeve, Test Chamber and Wrench
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
- No
- 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 |
|---|---|---|---|---|
| HQC | Unit, Phacofragmentation | Ophthalmic | 886.4670 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36215 | Phacoemulsification system handpiece tip, single-use | A device that is attached to a dedicated handpiece for insertion into the eye to deliver energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). It may facilitate, via the handpiece, the irrigation/suction needed for the removal of debris. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30818255010047 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 10818255010043 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K950880 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 30.0 | degree | |
| Needle Gauge | 20.0 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from direct sunlight