N/A

GUDID 10195291007122

Ceramic Low Profile Twin MBT .018 HK/3 W/CASE

Flexmedics

Orthodontic bracket, ceramic
Primary Device ID10195291007122
NIH Device Record Keyc2d70b26-9e2a-4753-b32a-a36e6d84b51d
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number61K-3-18-01
Company DUNS028853567
Company NameFlexmedics
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM
Phone317-346-6655
EmailORDERS@GHORTHO.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS110195291007122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, Ceramic, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-07-26
Device Publish Date2020-05-27

On-Brand Devices [N/A]

00195291009242VENUS ROTH CRMC UR2 022 8°T +9°A 5PK
00195291009235VENUS ROTH CRMC UR2 018 8°T +9°A 5PK
00195291009228VENUS ROTH CRMC UR1 022 12°T +5°A 5PK
00195291009211VENUS ROTH CRMC UL3 HK 022 0°T +11°A 4°M R 5PK
00195291009204VENUS ROTH CRMC UL2 022 8°T +9°A 5PK
00195291009198VENUS ROTH CRMC LR3 HK 022 11°T +2°A 5°M R 5PK
00195291009181VENUS ROTH CRMC LL3 HK 022 11°T +2°A 5°M R 5PK
00195291009174SG HI PULL HEADCAP REG.
00195291009167SG HI PULL HEADCAP JR
00195291009150SG CHIN CUP W/REG HEADCAP
00195291009143SG CHIN CUP W/JR HEADCAP
00195291009136SG CHIN CUP
10195291009126REVERSE PULL FACE MASK SM
10195291009119CHIN/FOREHEAD PADS-REVERSE PULL FACEMASK
10195291009102REVERSE PULL FACE MASK LG
10195291009096CHIN CUP FOR REVERSE PULL FACEMASK
00195291009082ROTH CRMC UP4/5 HK 022 5PK
00195291009075ROTH CRMC UP4/5 HK 018 5PK
00195291009068ROTH CRMC UR3 HK 022 5PK
00195291009051ROTH CRMC UR3 022 5PK
00195291009044ROTH CRMC UR3 HK 018 5PK
00195291009037ROTH CRMC UR3 018 5PK
00195291009020ROTH CRMC UR2 022 5PK
00195291009013ROTH CRMC UR2 018 5PK
00195291009006ROTH CRMC UR1 022 5PK
00195291008993ROTH CRMC UR1 018 5PK
00195291008986ROTH CRMC UL3 HK 022 5PK
00195291008979ROTH CRMC UL3 022 5PK
00195291008962ROTH CRMC UL3 HK 018 5PK
00195291008955ROTH CRMC UL3 018 5PK
00195291008948ROTH CRMC UL2 022 5PK
00195291008931ROTH CRMC UL2 018 5PK
00195291008924ROTH CRMC UL1 022 5PK
00195291008917ROTH CRMC UL1 018 5PK
00195291008900ROTH CRMC UP4/5 022 -7°T, 0°A 5PK
00195291008894ROTH CRMC UP4/5 018 -7°T, 0°A 5PK
00195291008887ROTH CRMC LO5 HK 022 5PK
00195291008870ROTH CRMC LO5 HK 018 5PK
00195291008863ROTH CRMC LO4 HK 022 5PK
00195291008856ROTH CRMC LO4 HK 018 5PK
00195291008849ROTH CRMC LR3 HK 022 -11°T, 5°A 5PK
00195291008832ROTH CRMC LR3 022 -11°T, 5°A 5PK
00195291008825ROTH CRMC LR3 HK 018 -11°T, 5°A 5PK
00195291008818ROTH CRMC LR3 018 -11°T, 5°A 5PK
00195291008801ROTH CRMC L1/2 022 0°T, 0°A 5PK
00195291008795ROTH CRMC L1/2 018 0°T, 0°A 5PK
00195291008788ROTH CRMC LL3 HK 022 -11°T, 5°A 5PK
00195291008771ROTH CRMC LL3 022 -11°T, 5°A 5PK
00195291008764ROTH CRMC LL3 HK 018 -11°T, 5°A 5PK
00195291008757ROTH CRMC LL3 018 -11°T, 5°A 5PK

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