| Primary Device ID | 00840199515455 |
| NIH Device Record Key | 644d4de9-1bea-4d7f-82ad-2440336301d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Drill Guide |
| Version Model Number | 7330-20 |
| Catalog Number | 7330-20 |
| Company DUNS | 007928633 |
| Company Name | KOROS U.S.A., INC. |
| Device Count | 1 |
| 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 | 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 |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com | |
| Phone | 1-805-529-0825 |
| customerservice@korosUSA.com |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840199515455 [Direct Marking] |
| GS1 | 10840199515452 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
[00840199515455]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-10 |
| Device Publish Date | 2024-05-31 |
| 00840199515479 | Drill Guide |
| 00840199515462 | Cervical Vert Distraction Drill Guide (Left) |
| 00840199515455 | Cervical Vert Distraction Drill Guide (Right) |
| 00840199515721 | Anterior Lumbar Drill Guide |