Burkhart Dental Supply

GUDID 00815878021176

Burkhart Level 3 Earloop Mask w/Chin Fit, Blue (50)

BURKHART DENTAL SUPPLY CO., THE

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use
Primary Device ID00815878021176
NIH Device Record Keyf901c416-e3eb-4df4-bbd1-1e8c7b563442
Commercial Distribution StatusIn Commercial Distribution
Brand NameBurkhart Dental Supply
Version Model Number72720528
Company DUNS027532357
Company NameBURKHART DENTAL SUPPLY CO., THE
Device Count50
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com
Phone1.800.562.8176
Emailcustomerservice@burkhartdental.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815878021169 [Primary]
GS100815878021176 [Unit of Use]
GS110815878021166 [Package]
Contains: 00815878021169
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-18
Device Publish Date2020-12-10

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00815878025440SS MIRROR HANDLE ROUND CONE SOCKET
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00815878025532Matrix System Refill Small Wedges Yellow (100)
00815878025525Matrix System Refill 6.6mm Tab Matrices (100)
00815878025518Matrix System Refill 5.5mm Tab Matrices (100)
00815878025501Matrix System Refill 4.5mm Tab Matrices (100)
00815878025495Matrix System Refill 3.5mm Tab Matrices (100)
00815878025488Matrix System Ring Refill Grey Narrow Rings (2)
00815878025471Matrix System Ring Refill Blk Standard Rings (2)
00815878025464Matrix System Starter Kit
00815878028472Varnish 5% NaF Fruity Bubblegum 0.4mL (50)
00815878020797Combo Tip High Volume Evacuator (50)
00810052610238#151 CRYER SERRATED UNIVERSAL FORCEPS
00810052610221#150 CRYER SERRATED UNIVERSAL FORCEPS
00810052610207KELLY SCI 6.25" CVD SERR ECON
00810052610191KELLY SCI 6.25" STR SERR ECON
00810052610184CROWN SCISSOR 4.5" CVD SERR ECON
00810052610177KELLY SCISSORS STRAIGHT 6.25" ECON
00810052610160KELLY SCISSORS CURVED 6.25" ECON
00810052610153SPENCER SUTURE SCISSORS 3.5" ECON
00810052610146IRIS SCISSORS STRAIGHT 4.5" ECON
00810052610139IRIS SCISSORS CURVED 4.5" ECON
00810052610122GOLDMAN-FOX SCISSORS CURVED 6.0" ECON
00810052610115DEAN GUM SCISSORS ANGLED 7.0" ECON
00810052610108CROWN & COLLAR SCISSORS CURVED 4.5" ECON
00810052610092BLUMENTHAL RONGEUR 5.5" 30° ECON
00810052610085FRIEDMAN RONGEUR 5.5" 30° ECON
00810052610078MAYO-HEAGR NEEDLE HOLDER 6" ECON
00810052610061BAUMGARTNER NEEDLE HOLDER 5.25" ECON
00810052610054CRILE-WOOD NEEDLE HOLDER 6" ECON
00810052610047CASTROVIEJO NEEDLE HOLDER 5.75" LOCKING ECON
00810052610030KELLY HEMOSTAT STRAIGHT 5.5"
00810052610023KELLY HEMOSTAT CURVED 5.5"
00810052610016HALSTEAD MOSQUITO FORCEPS STRAIGHT 4.75"
00810052610009HALSTEAD MOSQUITO FORCEPS CURVED 4.75"
00815878020681Yellow Pre-Bent Tip w/Brush End (100)
00815878020551Curved Brush Tips, Black (100)
00810052610955Disposable Mouth Mirror, White (60)
00810052610948Red Brush Tips 18GA (100)
008100526112596055-018SC Super Coarse FG Diamond (25)
00810052611242909-035SC Super Coarse FG Diamond (25)
00810052611235856-021SC Super Coarse FG Diamond (25)
00810052611228856-018SC Super Coarse FG Diamond (25)
00810052611211855-018SC Super Coarse FG Diamond (25)
00810052611204850-018SC Super Coarse FG Diamond (25)
00810052611198847-018SC Super Coarse FG Diamond (25)
00810052611181847-018C Course FG Diamond (25)
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