| Primary Device ID | 00840199514564 |
| NIH Device Record Key | 5f451638-120b-475c-976e-c297f2f5a766 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Axis Rongeur |
| Version Model Number | 7373-80 |
| Catalog Number | 7373-80 |
| 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 | |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840199514564 [Direct Marking] |
| GS1 | 10840199514561 [Primary] |
| HTX | Rongeur |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
[00840199514564]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-13 |
| Device Publish Date | 2024-02-05 |
| 00840199518821 | Axis Pituitary Rotating Rongeur Angled 4mm 7" |
| 00840199518814 | Axis Pituitary Rotating Rongeur Straight 4mm 7" |
| 00840199518807 | Axis Pituitary Rotating Rongeur Angled 3mm 7" |
| 00840199518791 | Axis Pituitary Rotating Rongeur Straight 3mm 7" |
| 00840199518784 | Axis Pituitary Rotating Rongeur Angled 2mm 7" |
| 00840199518777 | Axis Pituitary Rotating Rongeur Straight 2mm 7" |
| 00840199518760 | Axis Pituitary Rotating Rongeur Angled 1.5mm 7" |
| 00840199518753 | Axis Pituitary Rotating Rongeur Straight 1.5mm 7" |
| 00840199545711 | Axis Pituitary Rotating Rongeur SHAFT ONLY Angled 3mm 8" |
| 00840199545704 | Axis Pituitary Rotating Rongeur SHAFT ONLY Straight 3mm 8" |
| 00840199545698 | Axis Pituitary Rotating Rongeur SHAFT ONLY Angled 2mm 8" |
| 00840199545681 | Axis Pituitary Rotating Rongeur SHAFT ONLY Straight 2mm 8" |
| 00840199545674 | Axis Pituitary Rotating Rongeur SHAFT ONLY Angled 1.5mm 8" |
| 00840199545667 | Axis Pituitary Rotating Rongeur SHAFT ONLY Straight 1.5mm 8" |
| 00840199545650 | Axis Pituitary Rotating Rongeur SHAFT ONLY Angled 4mm 7" |
| 00840199545643 | Axis Pituitary Rotating Rongeur SHAFT ONLY Straight 4mm 7" |
| 00840199545629 | Axis Pituitary Rotating Rongeur SHAFT ONLY Straight 3mm 7" |
| 00840199545605 | Axis Pituitary Rotating Rongeur SHAFT ONLY Straight 2mm 7" |
| 00840199545582 | Axis Pituitary Rotating Rongeur SHAFT ONLY Straight 1.5mm 7" |
| 00840199514571 | 4mm Angled Axis Pituitary Rotating Rongeur 8" |
| 00840199514564 | 4mm Straight Axis Pituitary Rotating Rongeur 8" |
| 00840199514557 | 3mm Angled Axis Pituitary Rotating Rongeur 8" |
| 00840199514540 | 3mm Straight Axis Pituitary Rotating Rongeur 8" |
| 00840199514533 | 2mm Angled Axis Pituitary Rotating Rongeur 8" |
| 00840199514526 | 2mm Straight Axis Pituitary Rotating Rongeur 8" |
| 00840199514519 | 1.5mm Angled Axis Pituitary Rotating Rongeur 8" |
| 00840199514502 | 1.5mm Straight Axis Pituitary Rotating Rongeur 8" |