FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Eclipse MicroPen Elite
DI: 00853602008185
·
Model: MP1001-IISilver
·
ECLIPSE
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Eclipse MicroPen Elite
- Primary DI
- 00853602008185
- Version / Model
- MP1001-IISilver
- Catalog Number
- MP1001-IISilver
- Company Name
- ECLIPSE
- Labeler DUNS
- 969752364
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-04
- Public Version
- 2
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 50a1d26c-4eed-4850-8aa2-ded5c00a3dcc
- Distribution End Date
- 2019-08-31
Device Description
MicroPen ELITE - Includes, ELITE, Charger, 2 Batteries, A/C, Silver Case
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11177 | Skin abrasion unit | A mains electricity (AC-powered) device used for the removal of the skin surface by abrasion (applied by some kind of rotating abrasive tool, e.g., a wire brush or emery disc). It may be used during plastic surgery and can be used for treatments such as the removal of scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities of the skin. This GMDN code may reflect old technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853602008185 | GS1 |