FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 10818255011088
·
Model: N/A
·
MICROVISION, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 10818255011088
- Version / Model
- N/A
- Catalog Number
- 5257
- 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
- 5
- Public Version Date
- 2019-10-07
- Public Version Status
- Update
- Public Device Record Key
- 5b81ac13-2378-4d1e-a411-bc4396c3fcf6
Device Description
Dual Bore Subretinal BSS Injection Needle, 23Ga. with 0.1mm/41Ga. tip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| HMX | Cannula, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46705 | Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use | A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10818255011088 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 0.64mm tip O.D. | ||
| Device Size Text, specify | 6.0mm tip length | ||
| Needle Gauge | 41 | Gauge |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep away from direct sunlight