Ti Blade Retractor 1 7233-60

GUDID 10840199500250

KOROS U.S.A., INC.

External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system External spinal fixation system
Primary Device ID10840199500250
NIH Device Record Key6e29505b-f467-4d9b-9eb7-9b003d51aea1
Commercial Distribution StatusIn Commercial Distribution
Brand NameTi Blade Retractor 1
Version Model Number7233-60
Catalog Number7233-60
Company DUNS007928633
Company NameKOROS U.S.A., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com
Phone1-805-529-0825
Emailcustomerservice@korosUSA.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store in dry place at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100840199500253 [Direct Marking]
GS110840199500250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


[10840199500250]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-08
Device Publish Date2022-01-31

Devices Manufactured by KOROS U.S.A., INC.

00840199507511 - Rasp2024-06-10 Spinal Rasp Curved 3mm wide, 22cm
00840199515455 - Drill Guide2024-06-10 Cervical Vert Distraction Drill Guide (Right)
00840199515462 - Drill Guide2024-06-10 Cervical Vert Distraction Drill Guide (Left)
00840199515479 - Drill Guide2024-06-10 Drill Guide
00840199516216 - Nerve Stimulator Probe2024-06-10 Nerve Stimulator Dilator Probe 5.5mm
00840199517251 - Lamina Spreader2024-06-10 Lamina Spreader w/4 Teeth 10mm wide, 12"/31cm overall length, 7.5cm Deep
00840199517268 - Lamina Spreader2024-06-10 Laminia Spread 16mm,7.5cm dp
00840199517275 - Lamina Spreader2024-06-10 Angled Lamina Spreader w/4 Teeth 10mm wide, 12"/31cm overall length, 7.5cm Deep

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