Nerve Root Retractor 7233-54

GUDID 10840199500236

Nerve Root Retractor

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 ID10840199500236
NIH Device Record Key9315640d-e568-4236-94b9-656125220310
Commercial Distribution StatusIn Commercial Distribution
Brand NameNerve Root Retractor
Version Model Number7233-54
Catalog Number7233-54
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

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
GS100840199500239 [Direct Marking]
GS110840199500236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

Moist Heat or Steam Sterilization


[10840199500236]

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

On-Brand Devices [Nerve Root Retractor]

00840199508266Nerve Root Retractor Offset 11mm tip, 25.5cm long
00840199508259Nerve Root Retractor Offset 8mm tip, 25.5cm long
00840199508013Nerve Root Retractor 7mm tip, 10cm depth, 24cm overall length
00840199508006Nerve Root Retractor 4mm tip, 10cm depth, 24cm overall length
108401995002437233-56
10840199500236Nerve Root Retractor

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.