| 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 |
| 60849771028132 - NA | 2024-07-24 Polypropylene Channel Brush BLUE 16 INCH L 0.039 INCH DIAMETER |
| 60849771028149 - NA | 2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.039 INCH DIAMETER |
| 60849771028156 - NA | 2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.062 INCH DIAMETER |
| 60849771028163 - NA | 2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.062 INCH DIAMETER |
| 60849771028194 - NA | 2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.087 INCH DIAMETER |
| 60849771028200 - NA | 2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.087 INCH DIAMETER |
| 60849771028217 - NA | 2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.105 INCH DIAMETER |
| 60849771028224 - NA | 2024-07-24 Polypropylene Channel Brush CHNL BRUSH BLUE 16 INCH L 0.105 INCH DIAMETER |