Electro Lube EL201
GUDID 10724995225022
Electro Lube NXT is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
KEY SURGICAL, INC.
Electrosurgical electrode lubricant| Primary Device ID | 10724995225022 |
| NIH Device Record Key | 96357809-81c9-4eb1-a2ac-3c26afdd42e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Electro Lube |
| Version Model Number | EL201 |
| Catalog Number | EL201 |
| Company DUNS | 604056226 |
| Company Name | KEY SURGICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com | |
| Phone | +1(800)541-7995 |
| regulatory@keysurgical.com |
Device Dimensions
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
| Total Volume | 4 Milliliter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00724995225025 [Primary] |
| GS1 | 10724995225022 [Package] Contains: 00724995225025 Package: Box [20 Units] In Commercial Distribution |
| GS1 | 50724995225020 [Package] Package: Case [12 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241055
FDA Product Code
| GEI | Electrosurgical, cutting & coagulation & accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-11 |
| Device Publish Date | 2024-10-03 |
Devices Manufactured by KEY SURGICAL, INC.
| 10724995225022 - Electro Lube | 2024-10-11Electro Lube NXT is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking. |
| 10724995225022 - Electro Lube | 2024-10-11 Electro Lube NXT is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking. |
| 00849771048190 - NA | 2024-10-11 K-Wire and Steinmann Pin Dispensers, .062-inch (1.6mm) diameter, Holds k-wires up to 6-inch long |
| 00849771052562 - Key Surgical Pipe Cleaners | 2024-10-11 Pipe Cleaner, 1/8-inch Cotton, 50 feet |
| 00849771050131 - NA | 2024-10-11 Steinmann Pins, Double diamond, threaded, .177-inch (4.5mm) diameter, 9-inch long |
| 50849771050563 - NA | 2024-10-11 K-Wire Covers, Sterile, White, 2 per package |
| 50849771050624 - NA | 2024-10-11 Pin Covers, Sterile, Lavender, 2 per package |
| 50849771050655 - NA | 2024-10-11 Pin Covers, Sterile, Orange, 0.177-inch, 2 per package |
| 00849771048503 - NA | 2024-08-30 Instrument Trays and Covers, Mesh Tray with Drop Handles, 500 x 150 x 100mm |
Trademark Results [Electro Lube]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELECTRO LUBE 78616265 3164769 Live/Registered |
KVI LLC 2005-04-25 |
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