| Primary Device ID | 00840199529063 | 
| NIH Device Record Key | fcb68995-977f-4efc-aa86-6d651dbcd7d8 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Comfort Plus Chisel | 
| Version Model Number | 7543-30 | 
| Catalog Number | 7543-30 | 
| 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 | |
| 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 | 
| 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 | 00840199529063 [Direct Marking] | 
| GS1 | 10840199529060 [Primary] | 
| KDG | Chisel (Osteotome) | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
[00840199529063]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-02-08 | 
| Device Publish Date | 2024-01-31 | 
| 00840199529063 | Comfort Plus Chisel 30mm Tip 20cm Handles 32cm Total Length | 
| 00840199529056 | Comfort Plus Chisel 25mm Tip 20cm Handles 32cm Total Length | 
| 00840199529049 | Comfort Plus Chisel 20mm Tip 20cm Handles 32cm Total Length | 
| 00840199529032 | Comfort Plus Chisel 15mm Tip 20cm Handles 32cm Total Length | 
| 00840199529025 | Comfort Plus Chisel 10mm Tip 20cm Handles 32cm Total Length | 
| 00840199529018 | Comfort Plus Chisel 6mm Tip 20cm Handles 32cm Total Length | 
| 00840199529001 | Comfort Plus Chisel 30mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528998 | Comfort Plus Chisel 25mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528981 | Comfort Plus Chisel 20mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528974 | Comfort Plus Chisel 15mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528967 | Comfort Plus Chisel 10mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528950 | Comfort Plus Chisel 6mm Curved 16.5cm Handles 29cm Total Length | 
| 00840199528943 | Comfort Plus Chisel 30mm Straight 20cm Handles 32cm Total Length | 
| 00840199528936 | Comfort Plus Chisel 25mm Straight 20cm Handles 32cm Total Length | 
| 00840199528929 | Comfort Plus Chisel 20mm Straight 20cm Handles 32cm Total Length | 
| 00840199528912 | Comfort Plus Chisel 15mm Straight 20cm Handles 32cm Total Length | 
| 00840199528905 | Comfort Plus Chisel 10mm Straight 20cm Handles 32cm Total Length | 
| 00840199528899 | Comfort Plus Chisel 6mm Straight 20cm Handles 32cm Total Length | 
| 00840199528882 | Comfort Plus Chisel 30mm Straight 16.5cm Handles 29cm Total Length | 
| 10840199528872 | Comfort Plus Chisel 25mm Straight 16.5cm Handles 29cm Total Length | 
| 00840199528868 | Comfort Plus Chisel 20mm Straight 16.5cm Handles 29cm Total Length | 
| 00840199528851 | Comfort Plus Chisel 15mm Straight 16.5cm Handles 29cm Total Length | 
| 00840199528844 | Comfort Plus Chisel 10mm Straight 16.5cm Handles 29cm Total Length | 
| 00840199528837 | Comfort Plus Chisel 6m Straight 16.5cm 29cm Total Length |