FDA UDI
In Commercial Distribution
🇺🇸 United States
McKesson
DI: 10612479130002
·
Model: 16-4281
·
MCKESSON MEDICAL-SURGICAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- McKesson
- Primary DI
- 10612479130002
- Version / Model
- 16-4281
- Company Name
- MCKESSON MEDICAL-SURGICAL INC.
- Labeler DUNS
- 023904428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-16
- Public Version
- 1
- Public Version Date
- 2020-06-24
- Public Version Status
- New
- Public Device Record Key
- 225d0353-7c63-4b0f-a20f-64e18dfe4c20
Device Description
Eye Pads 1 5/8"X2 5/8"
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 | 20612479130016 | GS1 | Box | 50 | In Commercial Distribution | |
| Primary | 10612479130002 | GS1 | ||||
| Package | 40612479130027 | GS1 | Case | 12 | In Commercial Distribution |