FDA UDI
In Commercial Distribution
🇺🇸 United States
OptiDropper®, SafeFill™
DI: 00810080612501
·
Model: UA15-415-109-TRAY-5
·
MPS Pharma & Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OptiDropper®, SafeFill™
- Primary DI
- 00810080612501
- Version / Model
- UA15-415-109-TRAY-5
- Company Name
- MPS Pharma & Medical, Inc.
- Labeler DUNS
- 117970217
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-22
- Public Version
- 1
- Public Version Date
- 2025-10-30
- Public Version Status
- New
- Public Device Record Key
- 706897c8-c5a7-434d-b124-367ebccafa67
Device Description
15-415 Series 5mL OptiDropper®, Bottle Natural Boston Round SafeFill™ Tray
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
- Yes
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|---|---|
| Package | 10810080612508 | GS1 | CASE | 872 | In Commercial Distribution | |
| Primary | 00810080612501 | GS1 |