| Primary Device ID | 10840199500526 |
| NIH Device Record Key | 44b2261e-c94c-4377-a737-8bc0085cfff4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Round Bone Impactor |
| Version Model Number | 7224-54 |
| Catalog Number | 7224-54 |
| Company DUNS | 007928633 |
| Company Name | KOROS U.S.A., INC. |
| Device Count | 1 |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store in dry place at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840199500529 [Direct Marking] |
| GS1 | 10840199500526 [Primary] |
| KWP | Appliance, Fixation, Spinal Interlaminal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
[10840199500526]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-08 |
| Device Publish Date | 2022-01-31 |
| 10840199500519 | Round Bone Impactor 3mm |
| 10840199500540 | Round Bone Impactor 7.5mm |
| 10840199500533 | Round Bone Impactor 6mm |
| 10840199500526 | Round Bone Impactor 4mm |
| 10840199500502 | Round Bone Impactor 2mm |