| Primary Device ID | 00840199528745 | 
| NIH Device Record Key | d5c5c67e-7cea-4cd0-bce6-729ed38ba543 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Comfort Plus Osteotome | 
| Version Model Number | 7532-25 | 
| Catalog Number | 7532-25 | 
| 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 | 
| 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 | 00840199528745 [Direct Marking] | 
| GS1 | 10840199528742 [Primary] | 
| KDG | Chisel (Osteotome) | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
[00840199528745]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-01-08 | 
| Device Publish Date | 2024-12-31 | 
| 00840199528813 | Comfort Plus Osteotome 30mm Curved 20cm Handles 32cm Total Length | 
| 00840199528806 | Comfort Plus Osteotome 25mm Curved 20cm Handles 32cm Total Length | 
| 00840199528790 | Comfort Plus Osteotome 20mm Curved 20cm Handles 32cm Total Length | 
| 00840199528783 | Comfort Plus Osteotome 15mm Curved 20cm Handles 32cm Total Length | 
| 00840199528776 | Comfort Plus Osteotome 10mm Curved 20cm Handles 32cm Total Length | 
| 00840199528769 | Comfort Plus Osteotome 6mm Curved 20cm Handles 32cm Total Length | 
| 00840199528752 | Comfort Plus Osteotome 30mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528745 | Comfort Plus Osteotome 25mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528738 | Comfort Plus Osteotome 20mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528721 | Comfort Plus Osteotome 15mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528714 | Comfort Plus Osteotome 10mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528707 | Comfort Plus Osteotome 6mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528691 | Comfort Plus Osteotome 30mm Straight 20cm Handles 32cm Total Length | 
| 00840199528684 | Comfort Plus Osteotome 25mm Straight 20cm Handles 32cm Total Length | 
| 00840199528677 | Comfort Plus Osteotome 20mm Straight 20cm Handles 32cm Total Length | 
| 00840199528660 | Comfort Plus Osteotome 15mm Straight 20cm Handles 32cm Total Length | 
| 00840199528653 | Comfort Plus Osteotome 10mm Straight 20cm Handles 32cm Total Length | 
| 00840199528646 | Comfort Plus Osteotome 6mm Straight 20cm Handles 32cm Total Length | 
| 00840199528639 | Comfort Plus Osteotome 30mm Straight 16.5cm 29cm Total Length | 
| 00840199528622 | Comfort Plus Osteotome 25mm Straight 16.5cm 29cm Total Length | 
| 00840199528615 | Comfort Plus Osteotome 20mm Straight 16.5cm 29cm Total Length | 
| 00840199528592 | Comfort Plus Osteotome 15mm Straight 16.5cm Handles 29cm Total Length | 
| 00840199528578 | Comfort Plus Osteotome 10mm Straight 16.5cm Handles 29cm Total Length | 
| 00840199528561 | Comfort Plus Osteotome 6mm Straight 16.5cm Handles 29cm Total Length |