FDA UDI
In Commercial Distribution
🇺🇸 United States
ArtiSeal Vessel Sealing System - ArtiSeal Generator
DI: 08800042703066
·
Model: ASG-1000
·
LIVSMED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- ArtiSeal Vessel Sealing System - ArtiSeal Generator
- Primary DI
- 08800042703066
- Version / Model
- ASG-1000
- Company Name
- LIVSMED
- Labeler DUNS
- 688360116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-21
- Public Version
- 3
- Public Version Date
- 2026-04-23
- Public Version Status
- Update
- Public Device Record Key
- 560da952-1800-49aa-93f0-54695bf577f1
Device Description
This device is an electrosurgical unit intended to generate high-frequency (RF) energy. When the energy is applied to the human body through the compatible ArtiSeal Instruments, the current generates heat through tissue bioimpedance, which is utilized for the ligation (sealing) and division (cutting) of vessels.
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 11490 | Electrosurgical system generator | An electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues 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 generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); 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 | 08800042703066 | GS1 |
Customer Contacts
- Phone
- 8335487633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241138 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity