FDA UDI
In Commercial Distribution
🇺🇸 United States
Key Surgical Electro Lube
DI: 00849771037873
·
Model: EL-101
·
KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Key Surgical Electro Lube
- Primary DI
- 00849771037873
- Version / Model
- EL-101
- Company Name
- KEY SURGICAL, INC.
- Labeler DUNS
- 604056226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-11
- Public Version
- 3
- Public Version Date
- 2021-09-08
- Public Version Status
- Update
- Public Device Record Key
- 4a7cc300-dee2-45ab-b483-4daaddb0fa8d
Device Description
Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
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
- 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 |
|---|---|---|---|---|
| 64097 | Electrosurgical electrode lubricant | A solution intended to be applied to an electrosurgical electrode to help keep the distal tip of the electrode clean and free from debris during surgery by reducing tissue adhesion. It typically contains natural biocompatible phospholipids. After application this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10849771037870 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 00849771037873 | GS1 |
Customer Contacts
- Phone
- +1(800)541-7995
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033880 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 4 | Milliliter |