FDA UDI
In Commercial Distribution
🇺🇸 United States
Power Cord (OUS) 15 FT
DI: 08886479300207
·
Model: MS1222
·
Aerin Medical Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Power Cord (OUS) 15 FT
- Primary DI
- 08886479300207
- Version / Model
- MS1222
- Catalog Number
- CAT309-04
- Company Name
- Aerin Medical Inc.
- Labeler DUNS
- 051512253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-19
- Public Version
- 1
- Public Version Date
- 2023-10-27
- Public Version Status
- New
- Public Device Record Key
- 44842225-fe42-4f7a-88be-a466b298904f
Device Description
The power cord is an accessory for the Aerin Console which is an AC (alternating current) radiofrequency generator that incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44776 | Electrosurgical system | An assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08886479300207 | GS1 |
Customer Contacts
- Phone
- 833-484-8237
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162810 | 000 |