| Primary Device ID | 00849771013372 |
| NIH Device Record Key | 21ce0724-0179-4cc4-a09d-2b84d37d1140 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Key Surgical Cautery Tip Cleaner |
| Version Model Number | TC200NS |
| Catalog Number | TC200NS |
| Company DUNS | 604056226 |
| Company Name | KEY SURGICAL, INC. |
| Device Count | 1000 |
| 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 | true |
| RX Perscription | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849771013372 [Unit of Use] |
| GS1 | 10849771013379 [Primary] |
| GEI | Electrosurgical, cutting & coagulation & accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-14 |
| Device Publish Date | 2025-04-04 |
| 00849771030492 | Cautery Tip Cleaner, 50mm x 50mm, sterile, pouch |
| 00849771013372 | Cautery Tip Cleaner, 50mm x 50mm, sterile, pouch |