| Primary Device ID | 00840199519903 |
| NIH Device Record Key | b52b9221-afef-4611-9483-d6723bb9afc5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IVD Rongeur |
| Version Model Number | 7378-29 |
| Catalog Number | 7378-29 |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840199519903 [Direct Marking] |
| GS1 | 10840199519900 [Primary] |
| HTX | Rongeur |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
[00840199519903]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-09 |
| Device Publish Date | 2021-11-01 |
| 00840199520183 | Intervertebral Disk Rongeur Down-Angled 5mm 9" |
| 00840199520176 | Intervertebral Disk Rongeur Up-Angled 5mm 9" |
| 00840199520169 | Intervertebral Disk Rongeur Straight 5mm 9" |
| 00840199520152 | Intervertebral Disk Rongeur Down-Angled 4mm 9" |
| 00840199520145 | Intervertebral Disk Rongeur Up-Angled 4mm 9" |
| 00840199520138 | Intervertebral Disk Rongeur Straight 4mm 9" |
| 00840199520121 | Intervertebral Disk Rongeur Down-Angled 3mm 9" |
| 00840199520114 | Intervertebral Disk Rongeur Up-Angled 3mm 9" |
| 00840199520107 | Intervertebral Disk Rongeur Straight 3mm 9" |
| 00840199520091 | Intervertebral Disk Rongeur Down-Angled 2mm 9" |
| 00840199520084 | Intervertebral Disk Rongeur Up-Angled 2mm 9" |
| 00840199520077 | Intervertebral Disk Rongeur Straight 2mm 9" |
| 00840199520060 | Intervertebral Disk Rongeur Down-Angled 1.5mm 9" |
| 00840199520053 | Intervertebral Disk Rongeur Up-Angled 1.5mm 9" |
| 00840199520046 | Intervertebral Disk Rongeur Straight 1.5mm 9" |
| 00840199519989 | Intervertebral Disk Rongeur Serrated Down-Angled 5mm 8-1/4" |
| 00840199519972 | Intervertebral Disk Rongeur Down-Angled 5mm 8-1/4" |
| 00840199519941 | Intervertebral Disk Rongeur Serrated Down-Angled 4mm 8-1/4" |
| 00840199519934 | Intervertebral Disk Rongeur Down-Angled 4mm 8-1/4" |
| 00840199519927 | Intervertebral Disk Rongeur Serrated Down-Angled 3mm 8-1/4" |
| 00840199519910 | Intervertebral Disk Rongeur Down-Angled 3mm 8-1/4" |
| 00840199519903 | Intervertebral Disk Rongeur Down-Angled 2mm 8-1/4" |
| 00840199519897 | Intervertebral Disk Rongeur Serrated Down-Angled 2mm 8-1/4" |
| 00840199519880 | Intervertebral Disk Rongeur Down-Angled 1.5mm 8 1/4" |
| 00840199519873 | Intervertebral Disk Rongeur Serrated Down-Angled 1.5mm 8-1/4" |
| 00840199519705 | Intervertebral Disk Rongeur Serrated Up-Angled 5mm 8-1/4" |
| 00840199519699 | Intervertebral Disk Rongeur Up-Angeld 5mm 8-1/4" |
| 00840199519637 | Intervertebral Disk Rongeur Serrated Up-Angled 4mm 8-1/4" |
| 00840199519620 | Intervertebral Disk Rongeur Up-Angeld 4mm 8-1/4" |
| 00840199519583 | Intervertebral Disk Rongeur Serrated Up-Angled 3mm 8-1/4" |
| 00840199519576 | Intervertebral Disk Rongeur Up-Angled 3mm 8-1/4" |
| 00840199519569 | Intervertebral Disk Rongeur Up-Angled 2mm 8-1/4" |
| 00840199519507 | Intervertebral Disk Rongeur Serrated Up-Angled 2mm 8-1/4" |
| 00840199519484 | Intervertebral Disk Rongeur Up-Angled 1.5mm 8 1/4" |
| 00840199519477 | Intervertebral Disk Rongeur Serrated Up-Angled 1.5mm 8-1/4" |
| 00840199519316 | Intervertebral Disk Rongeur Serrated Straight 5mm 8-1/4" |
| 00840199519309 | Intervertebral Disk Rongeur Straight 5mm 8-1/4" |
| 00840199519200 | Intervertebral Disk Rongeur Serrated Straight 4mm 8-1/4" |
| 00840199519194 | Intervertebral Disk Rongeur Straight 4mm 8-1/4" |
| 00840199519170 | Intervertebral Disk Rongeur Serrated Straight 3mm 8-1/4" |
| 00840199519163 | Intervertebral Disk Rongeur Straight 3mm 8-1/4" |
| 00840199519156 | Intervertebral Disk Rongeur Serrated Straight 2mm 8-1/4" |
| 00840199519149 | Intervertebral Disk Rongeur Straight 2mm 8-1/4" |
| 00840199519132 | Intervertebral Disk Rongeur Straight 1.5mm 8 1/4" |
| 00840199519125 | Intervertebral Disk Rongeur Serrated Straight 1.5mm 8-1/4" |
| 00840199518937 | Intervertebral Disk Rongeur Serrated Down-Angled 5mm 7" |
| 00840199518913 | Intervertebral Disk Rongeur Serrated Down-Angled 4mm 7" |
| 00840199518906 | Intervertebral Disk Rongeur Down-Angled 4mm 7" |
| 00840199518883 | Intervertebral Disk Rongeur Serrated Down-Angled 3mm 7" |
| 00840199518876 | Intervertebral Disk Rongeur Down-Angled 3mm 7" |