| Primary Device ID | 10840199500045 |
| NIH Device Record Key | e2586c09-3c28-4a3c-a643-027e182c10cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Large Dilator Tube |
| Version Model Number | 7332-76D |
| Company DUNS | 007928633 |
| Company Name | KOROS U.S.A., INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 10840199500045 [Primary] |
| GXZ | Electrode, Needle |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
Moist Heat or Steam Sterilization
[10840199500045]
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 |
| 00840199528837 - Comfort Plus Chisel | 2025-02-10 Comfort Plus Chisel 6m Straight 16.5cm 29cm Total Length |
| 00840199507726 - Separator | 2025-01-08 Hoen Dura Separator 45 Degree 15cm 6" Length |
| 00840199507733 - Separator | 2025-01-08 Hoen Dura Separator 45 Degree 14mm Tip 21cm Length |
| 00840199507740 - Elevator | 2025-01-08 Delicate Cottle-Type Elevator 45 Degree 4mm x 6mm Tip 22cm 8-3/4" Lenth |
| 00840199507757 - Elevator | 2025-01-08 Adson Periosteal Elevator Chisel Edge 17cm |
| 00840199507764 - Elevator | 2025-01-08 Adson Periosteal Elevator Curved Blunt 17cm |
| 00840199507771 - Elevator | 2025-01-08 Adson Periosteal Elevator Straight Semi-Sharp 17cm |
| 00840199507788 - Elevator | 2025-01-08 Adson Periosteal Elevator Curved Semi-Sharp 17cm |