OP Rongeur 7376-44E

GUDID 00840199519286

Osteo-Punch Rongeur LS Ejector Tip 4mm x 40 Degree 8"

KOROS U.S.A., INC.

Craniofacial rongeur, reusable
Primary Device ID00840199519286
NIH Device Record Key1825be9e-6c11-41e5-98f1-cb949eaed8cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameOP Rongeur
Version Model Number7376-44E
Catalog Number7376-44E
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840199519286 [Direct Marking]
GS110840199519283 [Primary]

FDA Product Code

HTXRongeur

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

Moist Heat or Steam Sterilization

[00840199519286]

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 [OP Rongeur]

00840199519866Osteo-Punch Cutting Blade Ejector Tip Shaft Only 4mm x 40 Degree 8"
00840199519859Osteo-Punch Cutting Blade Ejector Tip Shaft Only 3mm x 40 Degree 8"
00840199519842Osteo-Punch Cutting Blade Ejector Tip Shaft Only 2mm x 40 Degree 8"
00840199519835Osteo-Punch Cutting Blade Ejector Tip Shaft Only 1mm x 40 Degree 8"
00840199519828Osteo-Punch Rongeur Multi-Bite Handle w/Spur 3mm
00840199519811Osteo-Punch Rongeur Multi-Bite Handle w/Spur 2mm
00840199519804Osteo-Punch Handle w/Spur 5mm
00840199519798Osteo-Punch Handle w/Spur 4mm
00840199519781Osteo-Punch Handle w/Spur 3mm
00840199519774Osteo-Punch Handle w/Spur 2mm
00840199519767Osteo-Punch Handle w/Spur 1mm
00840199519750Osteo-Punch Handle w/Spur 0.6mm
00840199519743Osteo-Punch Cutting Blade Shaft 4mm x 90 Degree 8"
00840199519736Osteo-Punch Cutting Blade Shaft 3mm x 90 Degree 8"
00840199519729Osteo-Punch Cutting Blade Shaft 2mm x 90 Degree 8"
00840199519712Osteo-Punch Cutting Blade Shaft 1mm x 90 Degree 8"
00840199519682Osteo-Punch Cutting Blade Shaft 5mm x 40 Degree 8"
00840199519675Osteo-Punch Cutting Blade Shaft 4mm x 40 Degree 8"
00840199519668Osteo-Punch Cutting Blade Shaft 3mm x 40 Degree 8"
00840199519651Osteo-Punch Cutting Blade Shaft 2mm x 40 Degree 8"
00840199519644Osteo-Punch Cutting Blade Shaft 1mm x 40 Degree 8"
00840199519613Osteo-Punch Cutting Blade Shaft 0.6mm x 40 Degree 8"
00840199519606Osteo-Punch Multi-Bite Shaft 3mm x 40 Degree 7"
00840199519590Osteo-Punch Multi-Bite Shaft 2mm x 40 Degree 7"
00840199519552Osteo-Punch Cutting Blade Shaft Only 4mm x 90 Degree 7"
00840199519545Osteo-Punch Cutting Blade Shaft Only 3mm x 90 Degree 7"
00840199519538Osteo-Punch Cutting Blade Ejector Tip Shaft Only 2mm x 90 Degree 7"
00840199519521Osteo-Punch Cutting Blade Shaft Only 2mm x 90 Degree 7"
00840199519514Osteo-Punch Cutting Blade Shaft Only 1mm x 90 Degree 7"
00840199519491Osteo-Punch Cutting Blade Shaft Only 0.6mm x 90 Degree 7"
00840199519460Osteo-Punch Cutting Blade Ejector Tip Shaft Only 4mm x 40 Degree 7"
00840199519453Osteo-Punch Cutting Blade Shaft Only 4mm x 40 Degree 7"
00840199519446Osteo-Punch Cutting Blade Ejector Tip Shaft Only 3mm x 40 Degree 7"
00840199519439Osteo-Punch Cutting Blade Shaft Only 3mm x 40 Degree 7"
00840199519422Osteo-Punch Cutting Blade Ejector Tip Shaft Only 2mm x 40 Degree 7"
00840199519415Osteo-Punch Cutting Blade Shaft Only 2mm x 40 Degree 7"
00840199519408Osteo-Punch Cutting Blade Ejector Tip Shaft Only 1mm x 40 Degree 7"
00840199519392Osteo-Punch Cutting Blade Shaft Only 1mm x 40 Degree 7"
00840199519385Osteo-Punch Cutting Blade Shaft Only 0.6mm x 40 Degree 7"
00840199519378Osteo-Punch Rongeur LS 4mm x 90 Degree 8"
00840199519361Osteo-Punch Rongeur LS 3mm x 90 Degree 8"
00840199519354Osteo-Punch Rongeur LS 2mm x 90 Degree 8"
00840199519347Osteo-Punch Rongeur LS 1mm x 90 Degree 8"
00840199519293Osteo-Punch Rongeur LS 5mm x 40 Degree 8"
00840199519286Osteo-Punch Rongeur LS Ejector Tip 4mm x 40 Degree 8"
00840199519279Osteo-Punch Rongeur LS 4mm x 40 Degree 8"
00840199519262Osteo-Punch Rongeur LS Ejector Tip 3mm x 40 Degree 8"
00840199519255Osteo-Punch Rongeur LS 3mm x 40 Degree 8"
00840199519248Osteo-Punch Rongeur LS Ejector Tip 2mm x 40 Degree 8"
00840199519231Osteo-Punch Rongeur LS 2mm x 40 Degree 8"
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.