ALMORE BITE REGISTRATION SHEETS

GUDID D248426000

BITE REGISTRATION SHEETS

HAGER WORLDWIDE, INC.

Bite registration rim wax
Primary Device IDD248426000
NIH Device Record Key73bb2d2b-6829-4542-92d2-da062bcd2778
Commercial Distribution Discontinuation2023-08-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameALMORE BITE REGISTRATION SHEETS
Version Model Number42600
Company DUNS009277971
Company NameHAGER WORLDWIDE, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com
Phone+1(828)624-3319
Emaild.pritchard@hagerworldwide.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD248426000 [Primary]

FDA Product Code

EGDWAX, DENTAL, INTRAORAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-13
Device Publish Date2022-12-08

Devices Manufactured by HAGER WORLDWIDE, INC.

D2486300620 - TS1 Tongue Vacuum Cleaner2024-08-28 Tongue scraper
D2483552470 - The Prepster (also known as LaminateButler)2024-07-23 Chairside organizer for dental restorative cases
D2483552520 - BurButler ( 5 Hole Orange Base w/Lid)2024-07-23 Dental bur holder
D2483552530 - BurButler ( 10 Hole White Base w/Lid)2024-07-23 Dental bur holder
D2483552540 - BurButler ( 10 Hole Pink Base w/Lid)2024-07-23 Dental bur holder
D2483552560 - BurButler ( 10 Hole Blue Base w/Lid)2024-07-23 Dental bur holder
D2483552600 - BurButler ( 25 Hole Pink Base w/Lid)2024-07-23 Dental bur holder
D2483552620 - BurButler ( 25 Hole Blue Base w/Lid)2024-07-23 Dental bur holder

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