| Primary Device ID | 00849771051466 |
| NIH Device Record Key | 55a00f40-29c0-4ad7-bc35-8802c8196355 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bone Reamer Brushes |
| Version Model Number | BR31197 |
| Catalog Number | BR31197 |
| Company DUNS | 604056226 |
| Company Name | KEY SURGICAL, INC. |
| Device Count | 3 |
| 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 | true |
| 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 |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Length | 31 Inch |
| Outer Diameter | 0.197 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849771031642 [Previous] |
| GS1 | 00849771051466 [Unit of Use] |
| GS1 | 10849771051463 [Primary] |
| HTO | REAMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00849771051466]
Moist Heat or Steam Sterilization
[00849771051466]
Moist Heat or Steam Sterilization
[00849771051466]
Moist Heat or Steam Sterilization
[00849771051466]
Moist Heat or Steam Sterilization
[00849771051466]
Moist Heat or Steam Sterilization
[00849771051466]
Moist Heat or Steam Sterilization
[00849771051466]
Moist Heat or Steam Sterilization
[00849771051466]
Moist Heat or Steam Sterilization
[00849771051466]
Moist Heat or Steam Sterilization
[00849771051466]
Moist Heat or Steam Sterilization
[00849771051466]
Moist Heat or Steam Sterilization
[00849771051466]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-01 |
| Device Publish Date | 2024-03-22 |
| 00849771046646 | Bone Reamer Brush, Nylon bristles, stainless steel handle, .118" diam, 31" long, pkg/3 |
| 00849771046653 | Bone Reamer Brush, Nylon bristles, stainless steel handle, .197" diam, 31" long, pkg/3 |
| 00849771046660 | Bone Reamer Brush, Nylon bristles, stainless steel handle, .276" diam, 31" long, pkg/3 |
| 00849771051466 | Bone Reamer Brush, Nylon bristles, stainless steel handle, .197-inch diam, 31-inch long, 3 per p |