FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Electro Lavage
DI: 00817984010488
·
Model: 0600-3120-000
·
MECTRA LABS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Electro Lavage
- Primary DI
- 00817984010488
- Version / Model
- 0600-3120-000
- Catalog Number
- 0600-3120-000
- Company Name
- MECTRA LABS, INC.
- Labeler DUNS
- 606939072
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-25
- Public Version
- 3
- Public Version Date
- 2024-08-07
- Public Version Status
- Update
- Public Device Record Key
- e4b72685-914f-43f3-b87a-dac9059c0161
- Distribution End Date
- 2020-01-10
Device Description
Electro Lavage J Hook
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 58039 | Endoscopic electrosurgical handpiece/electrode, monopolar, single-use | An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10817984010485 | GS1 | Inner pack | 10 | Not in Commercial Distribution | 2020-01-10 |
| Primary | 00817984010488 | GS1 |
Customer Contacts
- Phone
- +1(800)323-3968
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 115 Degrees Fahrenheit