FDA UDI
In Commercial Distribution
🇺🇸 United States
INTRAgen Tip
DI: 08800020105028
·
Model: KT-07
·
Jeisys Medical Inc.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- INTRAgen Tip
- Primary DI
- 08800020105028
- Version / Model
- KT-07
- Company Name
- Jeisys Medical Inc.
- Labeler DUNS
- 690275362
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ebec6460-460c-4e45-96ad-2760686d4316
Device Description
Sterile electrode
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
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OUH | Skin Resurfacing Rf Applicator | General, Plastic Surgery | 878.4400 | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45048 | Radio-frequency skin contouring system applicator tip | A removable endpiece that is attached to a radio-frequency (RF) skin contouring system applicator (handpiece), used to regulate the delivery of RF energy to the patient during treatment. As a procedural safety measure, the device may permit the transfer of energy only when a correct surface contact is established. It may also be used to cool the skin and monitor its temperature to protect the epidermis during treatment. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 28800020105022 | GS1 | Big box | 5 | In Commercial Distribution | |
| Package | 18800020105025 | GS1 | Small box | 10 | In Commercial Distribution | |
| Primary | 08800020105028 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K142833 | 000 |