| Primary Device ID | 00840199528806 |
| NIH Device Record Key | a06bf216-2592-44da-bcbc-e8e5ece7ea32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comfort Plus Osteotome |
| Version Model Number | 7533-25 |
| Catalog Number | 7533-25 |
| 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 | 00840199528806 [Direct Marking] |
| GS1 | 10840199528803 [Primary] |
| KDG | Chisel (Osteotome) |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
Moist Heat or Steam Sterilization
[00840199528806]
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 |