IVD Rongeur 7378-16

GUDID 00840199519880

Intervertebral Disk Rongeur Down-Angled 1.5mm 8 1/4"

KOROS U.S.A., INC.

Craniofacial rongeur, reusable
Primary Device ID00840199519880
NIH Device Record Key3abb63ee-24eb-484f-859e-ecc87cf11133
Commercial Distribution StatusIn Commercial Distribution
Brand NameIVD Rongeur
Version Model Number7378-16
Catalog Number7378-16
Company DUNS007928633
Company NameKOROS U.S.A., INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Dimensions

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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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840199519880 [Direct Marking]
GS110840199519887 [Primary]

FDA Product Code

HTXRongeur

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

[00840199519880]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-09
Device Publish Date2021-11-01

On-Brand Devices [IVD Rongeur]

00840199520183Intervertebral Disk Rongeur Down-Angled 5mm 9"
00840199520176Intervertebral Disk Rongeur Up-Angled 5mm 9"
00840199520169Intervertebral Disk Rongeur Straight 5mm 9"
00840199520152Intervertebral Disk Rongeur Down-Angled 4mm 9"
00840199520145Intervertebral Disk Rongeur Up-Angled 4mm 9"
00840199520138Intervertebral Disk Rongeur Straight 4mm 9"
00840199520121Intervertebral Disk Rongeur Down-Angled 3mm 9"
00840199520114Intervertebral Disk Rongeur Up-Angled 3mm 9"
00840199520107Intervertebral Disk Rongeur Straight 3mm 9"
00840199520091Intervertebral Disk Rongeur Down-Angled 2mm 9"
00840199520084Intervertebral Disk Rongeur Up-Angled 2mm 9"
00840199520077Intervertebral Disk Rongeur Straight 2mm 9"
00840199520060Intervertebral Disk Rongeur Down-Angled 1.5mm 9"
00840199520053Intervertebral Disk Rongeur Up-Angled 1.5mm 9"
00840199520046Intervertebral Disk Rongeur Straight 1.5mm 9"
00840199519989Intervertebral Disk Rongeur Serrated Down-Angled 5mm 8-1/4"
00840199519972Intervertebral Disk Rongeur Down-Angled 5mm 8-1/4"
00840199519941Intervertebral Disk Rongeur Serrated Down-Angled 4mm 8-1/4"
00840199519934Intervertebral Disk Rongeur Down-Angled 4mm 8-1/4"
00840199519927Intervertebral Disk Rongeur Serrated Down-Angled 3mm 8-1/4"
00840199519910Intervertebral Disk Rongeur Down-Angled 3mm 8-1/4"
00840199519903Intervertebral Disk Rongeur Down-Angled 2mm 8-1/4"
00840199519897Intervertebral Disk Rongeur Serrated Down-Angled 2mm 8-1/4"
00840199519880Intervertebral Disk Rongeur Down-Angled 1.5mm 8 1/4"
00840199519873Intervertebral Disk Rongeur Serrated Down-Angled 1.5mm 8-1/4"
00840199519705Intervertebral Disk Rongeur Serrated Up-Angled 5mm 8-1/4"
00840199519699Intervertebral Disk Rongeur Up-Angeld 5mm 8-1/4"
00840199519637Intervertebral Disk Rongeur Serrated Up-Angled 4mm 8-1/4"
00840199519620Intervertebral Disk Rongeur Up-Angeld 4mm 8-1/4"
00840199519583Intervertebral Disk Rongeur Serrated Up-Angled 3mm 8-1/4"
00840199519576Intervertebral Disk Rongeur Up-Angled 3mm 8-1/4"
00840199519569Intervertebral Disk Rongeur Up-Angled 2mm 8-1/4"
00840199519507Intervertebral Disk Rongeur Serrated Up-Angled 2mm 8-1/4"
00840199519484Intervertebral Disk Rongeur Up-Angled 1.5mm 8 1/4"
00840199519477Intervertebral Disk Rongeur Serrated Up-Angled 1.5mm 8-1/4"
00840199519316Intervertebral Disk Rongeur Serrated Straight 5mm 8-1/4"
00840199519309Intervertebral Disk Rongeur Straight 5mm 8-1/4"
00840199519200Intervertebral Disk Rongeur Serrated Straight 4mm 8-1/4"
00840199519194Intervertebral Disk Rongeur Straight 4mm 8-1/4"
00840199519170Intervertebral Disk Rongeur Serrated Straight 3mm 8-1/4"
00840199519163Intervertebral Disk Rongeur Straight 3mm 8-1/4"
00840199519156Intervertebral Disk Rongeur Serrated Straight 2mm 8-1/4"
00840199519149Intervertebral Disk Rongeur Straight 2mm 8-1/4"
00840199519132Intervertebral Disk Rongeur Straight 1.5mm 8 1/4"
00840199519125Intervertebral Disk Rongeur Serrated Straight 1.5mm 8-1/4"
00840199518937Intervertebral Disk Rongeur Serrated Down-Angled 5mm 7"
00840199518913Intervertebral Disk Rongeur Serrated Down-Angled 4mm 7"
00840199518906Intervertebral Disk Rongeur Down-Angled 4mm 7"
00840199518883Intervertebral Disk Rongeur Serrated Down-Angled 3mm 7"
00840199518876Intervertebral Disk Rongeur Down-Angled 3mm 7"
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