FDA UDI
In Commercial Distribution
🇺🇸 United States
ArtiSeal Vessel Sealing System - ArtiSeal Instruments
DI: 08800042703059
·
Model: AS01L
·
LIVSMED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ArtiSeal Vessel Sealing System - ArtiSeal Instruments
- Primary DI
- 08800042703059
- Version / Model
- AS01L
- 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
- 2
- Public Version Date
- 2026-04-23
- Public Version Status
- Update
- Public Device Record Key
- 9c92c192-89ba-4c5a-94ce-665fa3d8862d
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
- 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 |
|---|---|---|---|---|
| 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 | 08800042703059 | GS1 |
Customer Contacts
- Phone
- 8335487633
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K241138 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Shaft Length | 41.5 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity