GUDID 00190886135559

OCS UTILITY ROPE WAX (120 STRIPS)

G & H Wire Company, Inc.

Orthodontic appliance relief material
Primary Device ID00190886135559
NIH Device Record Key83d032f9-4b4d-4523-8b23-078d04602aa7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number700-111
Company DUNS831465641
Company NameG & H Wire Company, Inc.
Device Count120
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com
Phone+1(317)346-6655
Emailorders@ghortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190886135559 [Unit of Use]
GS110190886135556 [Primary]

FDA Product Code

EGDWAX, DENTAL, INTRAORAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

Devices Manufactured by G & H Wire Company, Inc.

10190886051276 - NA2025-04-08 BLACK COATED FACEBOW, UNIV
10190886051283 - NA2025-04-08 BLUE COATED FACEBOW, UNIV
10190886051290 - NA2025-04-08 WHITE COATED FACEBOW, UNIV
10190886051306 - NA2025-04-08 ORANGE COATED FACEBOW, UNIV
10190886051313 - NA2025-04-08 DARK GREEN COATED FACEBOW, UNIV
10190886051320 - NA2025-04-08 LIME GREEN COATED FACEBOW, UNIV
10190886051337 - NA2025-04-08 YELLOW COATED FACEBOW, UNIV
10190886051344 - NA2025-04-08 PURPLE COATED FACEBOW, UNIV

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