FDA UDI
In Commercial Distribution
🇺🇸 United States
American White Cross
DI: 10665973018079
·
Model: 17576
·
Dukal LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- American White Cross
- Primary DI
- 10665973018079
- Version / Model
- 17576
- Catalog Number
- 17576
- Company Name
- Dukal LLC
- Labeler DUNS
- 791014871
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-12-06
- Public Version
- 1
- Public Version Date
- 2022-12-14
- Public Version Status
- New
- Public Device Record Key
- 5bcd57fe-a2fb-4caa-beb8-140d0bf611b9
Device Description
Eye Pad 1-5/8" x 2-5/8", Sterile
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
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HMP | PAD, EYE | General, Plastic Surgery | 878.4440 | 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 |
|---|---|---|---|---|---|---|
| Package | 30665973018073 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 10665973018079 | GS1 | ||||
| Unit of Use | 00665973018072 | GS1 |
Customer Contacts
- Phone
- +1(631)656-3800 ext. 172
- [email protected]