Primary Device ID | 00840199500284 |
NIH Device Record Key | 553b2676-9721-4d24-8204-8db283ad4ace |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ti blade Retractors 4 |
Version Model Number | 7233-66 |
Catalog Number | 7233-66 |
Company DUNS | 007928633 |
Company Name | KOROS U.S.A., INC. |
Device Count | 1 |
DM Exempt | false |
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 |
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 | 00840199500284 [Direct Marking] |
GS1 | 10840199500281 [Primary] |
KWP | Appliance, Fixation, Spinal Interlaminal |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840199500284]
Moist Heat or Steam Sterilization
[00840199500284]
Moist Heat or Steam Sterilization
[00840199500284]
Moist Heat or Steam Sterilization
[00840199500284]
Moist Heat or Steam Sterilization
[00840199500284]
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 |
00840199507511 - Rasp | 2024-06-10 Spinal Rasp Curved 3mm wide, 22cm |
00840199515455 - Drill Guide | 2024-06-10 Cervical Vert Distraction Drill Guide (Right) |
00840199515462 - Drill Guide | 2024-06-10 Cervical Vert Distraction Drill Guide (Left) |
00840199515479 - Drill Guide | 2024-06-10 Drill Guide |
00840199516216 - Nerve Stimulator Probe | 2024-06-10 Nerve Stimulator Dilator Probe 5.5mm |
00840199517251 - Lamina Spreader | 2024-06-10 Lamina Spreader w/4 Teeth 10mm wide, 12"/31cm overall length, 7.5cm Deep |
00840199517268 - Lamina Spreader | 2024-06-10 Laminia Spread 16mm,7.5cm dp |
00840199517275 - Lamina Spreader | 2024-06-10 Angled Lamina Spreader w/4 Teeth 10mm wide, 12"/31cm overall length, 7.5cm Deep |