| Primary Device ID | 00840199542345 | 
| NIH Device Record Key | ebf0db51-8d98-4bcd-897f-277cabe0c030 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Vein Retractor | 
| Version Model Number | 9900-80 | 
| Catalog Number | 9900-80 | 
| 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 | 
| 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 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00840199542345 [Direct Marking] | 
| GS1 | 10840199542342 [Primary] | 
| GAD | Retractor | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00840199542345]
Moist Heat or Steam Sterilization
[00840199542345]
Moist Heat or Steam Sterilization
[00840199542345]
Moist Heat or Steam Sterilization
[00840199542345]
Moist Heat or Steam Sterilization
[00840199542345]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-11-08 | 
| Device Publish Date | 2022-10-31 | 
| 00840199542345 | Vein Retractor 1/2" Wide x 1/2" Deep | 
| 00840199507993 | Vein Retractor 13mm Blade 23cm 9" Length | 
| 00840199507986 | Vein Retractor 7mm Blade 23cm 9" Length | 
| 00840199507979 | Vein Retractor 4mm Blade 23cm 9" Length |