FDA UDI
In Commercial Distribution
🇺🇸 United States
LERNA
DI: 00896180011741
·
Model: 222-01
·
Lernapharm (Loris) Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LERNA
- Primary DI
- 00896180011741
- Version / Model
- 222-01
- Company Name
- Lernapharm (Loris) Inc
- Labeler DUNS
- 206940905
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-28
- Public Version
- 2
- Public Version Date
- 2023-11-23
- Public Version Status
- Update
- Public Device Record Key
- 751f6e91-6b21-462d-812b-89bc35980b87
Device Description
Skin Protectant Prep Pad
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
- 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 |
|---|---|---|---|---|
| NEC | Bandage, Liquid, Skin Protectant | General Hospital | 880.5090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65285 | Skin adhesive protective material | A liquid preparation designed to be applied evenly over intact skin to form a synthetic polymer film, prior to application of an adhesive strip/bandage, to protect the skin during subsequent removal of the adhesive strip/bandage. It may be presented as a wipe/swab. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00896180011741 | GS1 |