FDA UDI
In Commercial Distribution
🇺🇸 United States
Posey Eye Protection
DI: 10852788008153
·
Model: NL-EP-01S-NEWBORN
·
NEOLIGHT LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Posey Eye Protection
- Primary DI
- 10852788008153
- Version / Model
- NL-EP-01S-NEWBORN
- Company Name
- NEOLIGHT LLC
- Labeler DUNS
- 074301687
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-06
- Public Version
- 1
- Public Version Date
- 2020-11-16
- Public Version Status
- New
- Public Device Record Key
- d93979de-99c7-45d5-9794-c8a7b4cf30c0
Device Description
Eye protection for newborn phototherapy - sized for newborn patients
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FOK | Pad, Neonatal Eye | General Hospital | 880.5270 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11661 | Eye pad | A cushion-like device made of various materials (e.g., gauze, cotton) intended to protect the eye or to absorb eye secretions. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10852788008153 | GS1 | ||||
| Package | 20852788008150 | GS1 | Box | 5 | In Commercial Distribution |