FDA UDI
In Commercial Distribution
🇺🇸 United States
ArtiSeal Vessel Sealing System - ArtiSeal Instruments
DI: 08800042703042
·
Model: AS01M
·
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 Instruments
- Primary DI
- 08800042703042
- Version / Model
- AS01M
- Company Name
- LIVSMED
- Labeler DUNS
- 688360116
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-17
- Public Version
- 1
- Public Version Date
- 2026-04-27
- Public Version Status
- New
- Public Device Record Key
- 7438e2c2-0f76-486f-956d-ffe1d949b41c
Device Description
This device is an electrosurgical instrument intended to be used in conjunction with the ArtiSeal Generator. It delivers high-frequency (RF) energy to the human body. The current flowing into the tissue generates heat through bioimpedance, which is utilized for the ligation (sealing) and division (cutting) of vessels.
Device Characteristics
- Single Use
- Yes
- 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
- 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
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 |
|---|---|---|---|---|
| 57944 | Endoscopic electrosurgical handpiece/electrode, bipolar, single-use | A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800042703042 | GS1 |
Customer Contacts
- Phone
- 8335487633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250126 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Shaft Length | 345 | Millimeter | |
| Outer Diameter | 8 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius