N/A

GUDID 10195291006125

Ceramic Twin MBT .018 HK/345 W/CASE

FLEXMEDICS

Orthodontic bracket, ceramic

• Primary Device ID: 10195291006125
• NIH Device Record Key: 9e42b412-fe4d-490c-bc02-05c531d1199a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 57K-345-18-01
• Company DUNS: 028853567
• Company Name: FLEXMEDICS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM
• Phone: 317-346-6655
• Email: ORDERS@GHORTHO.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	10195291006125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132368

FDA Product Code

• NJM: Bracket, Ceramic, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-03
• Device Publish Date: 2020-05-26

On-Brand Devices [N/A]

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