FDA UDI
In Commercial Distribution
🇺🇸 United States
MD Ophthalmic Dropper Bottles
DI: 00338779559246
·
Model: 5592-04
·
Medisca Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- MD Ophthalmic Dropper Bottles
- Primary DI
- 00338779559246
- Version / Model
- 5592-04
- Catalog Number
- 5592-04
- Company Name
- Medisca Inc.
- Labeler DUNS
- 794301960
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-05-12
- Public Version
- 1
- Public Version Date
- 2023-05-22
- Public Version Status
- New
- Public Device Record Key
- e8b7061d-7032-4c9d-82c7-de414d45041d
Device Description
MD Ophthalmic Dropper Bottles, 15 mL, Sterile, Ready-to-fill, Clear with White Caps
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYX | Dispenser, Liquid Medication | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61338 | Eye dropper bottle | A sterile device intended to store and dispense in drops an eye irrigation solution typically to flush the eye of irritating particulates/chemicals, or to treat a specific eye condition. It does not contain eye irrigation solution. It consists of a small bottle with a nozzle which acts as a dropper spout. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10338779559243 | GS1 | ||||
| Primary | 00338779559246 | GS1 |