| Primary Device ID | 60849771028538 |
| NIH Device Record Key | 961c7962-91b4-43f7-b1a9-457f32589dc9 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | PT28197 |
| Catalog Number | PT28197 |
| 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 | 00849771028536 [Primary] |
| GS1 | 60849771028538 [Unit of Use] |
| MNL | ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
Moist Heat or Steam Sterilization
[60849771028538]
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 |
| 00849771052159 - NA | 2025-08-27 Dry Endoscopy Sponge, 2-inch OD x 0.50-inch ID x 3.75-inch Long |
| 00849771048237 - NA | 2025-08-19 K-Wire and Steinmann Pin Dispensers, 5/64-inch (2.0mm) diameter, Holds pins up to 12-inch long |
| 00849771049036 - NA | 2025-08-19 K-Wires, Single trocar, .035-inch (.9mm) diameter, 4-inch long |
| 00849771049289 - NA | 2025-08-19 K-Wires, Single trocar, .062-inch (1.6mm) diameter, 6-inch long |
| 00849771049500 - NA | 2025-08-19 K-Wires, Single diamond, round end, .062-inch (1.6mm) diameter, 12-inch |
| 00849771048169 - NA | 2025-05-08 K-Wire and Steinmann Pin Dispensers, .035 inch .9mm diameter, Holds kwires up to 6 inch long |
| 00849771049012 - NA | 2025-05-08 K-Wires, Double trocar, .054-inch (1.4mm) diameter, 12-inch long |
| 00849771049128 - NA | 2025-05-08 K-Wires, Single trocar, .035-inch (.9mm) diameter, 12-inch long |