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
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 |
| 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.
| 00849771046356 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 20 |
| 00849771046363 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 22 |
| 00849771046370 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 24 |
| 00849771046387 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 25 |
| 00849771046394 - K-Wire and Steinmann Pin Dispensers | 2025-04-24 K-Wire and Steinmann Pin Dispensers, Dispensing Hole, 18.5-inch Etch w/ 26 |
| 00849771013372 - Key Surgical Cautery Tip Cleaner | 2025-04-14 Cautery Tip Cleaner, 50mm x 50mm, sterile, pouch |
| 50849771050617 - NA | 2025-03-17 Pin Covers, Sterile, Tan, 2 per package |
| 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. |
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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