| Primary Device ID | 60849771028453 |
| NIH Device Record Key | 72f09cba-133e-48ea-b396-9b3cc1dd60a1 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | PP22105 |
| Catalog Number | PP22105 |
| Company DUNS | 604056226 |
| Company Name | KEY SURGICAL, INC. |
| Device Count | 2 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00849771028451 [Primary] |
| GS1 | 60849771028453 [Unit of Use] |
| MNL | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
[60849771028453]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-24 |
| Device Publish Date | 2024-07-16 |
| 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 |