30 deg Offset Impactor 7222-20

GUDID 10840199500304

30 deg Offset Impactor

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 ID10840199500304
NIH Device Record Key3d52eeaf-8bdf-450e-94c4-96d25d95fce1
Commercial Distribution StatusIn Commercial Distribution
Brand Name30 deg Offset Impactor
Version Model Number7222-20
Catalog Number7222-20
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

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Device Size Text, specify0
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Device Size Text, specify0
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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
GS100840199500307 [Direct Marking]
GS110840199500304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

Moist Heat or Steam Sterilization


[10840199500304]

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 [30 deg Offset Impactor]

1084019950031130 deg Offset Impactor
1084019950030430 deg Offset Impactor
1084019950029830 deg Offset Impactor

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