FDA UDI
In Commercial Distribution
🇺🇸 United States
WavelinQ
DI: 00801741218033
·
Model: ESU2
·
CLEARSTREAM TECHNOLOGIES LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WavelinQ
- Primary DI
- 00801741218033
- Version / Model
- ESU2
- Catalog Number
- ESU2
- Company Name
- CLEARSTREAM TECHNOLOGIES LIMITED
- Labeler DUNS
- 989214291
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-17
- Public Version
- 3
- Public Version Date
- 2024-06-25
- Public Version Status
- Update
- Public Device Record Key
- a6de1d58-77a1-4c09-8797-3d7683c511dc
Device Description
WavelinQ Generator
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
- 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 | 00801741218033 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222793 | 000 |