FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Eclipse MicroPen Elite
DI: 00853602008376
·
Model: MP1002-CA-K12HA-S
·
ECLIPSE
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Eclipse MicroPen Elite
- Primary DI
- 00853602008376
- Version / Model
- MP1002-CA-K12HA-S
- Catalog Number
- MP1002-CA-K12HA-S
- 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
- 5
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- 41bb9c98-824f-4a3c-b700-36d5e7b9ab10
- Distribution End Date
- 2019-05-03
Device Description
Cosmetic Applicator Kit HA without MicroSleeves (12 CA / Pkg)
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61222 | Cosmetic micro-needling electronic handpiece cartridge, professional | A device intended to be fitted to an electronic cosmetic micro-needling handpiece for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It is a small, sealed cartridge containing micro-needles intended to be fitted to the distal tip of the handpiece; it does not include any injectable materials. It is intended to be used by a healthcare provider in a clinical setting. It is not intended to be used for energy-based skin treatment. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853602008376 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- – 40 Degrees Celsius