Quantum

GUDID 00190707005993

Quantum .018 UL/R 4/5 HK -7T

ORTHO ORGANIZERS, INC.

Orthodontic bracket, plastic, single-use

• Primary Device ID: 00190707005993
• NIH Device Record Key: 86fbb447-d3a4-4bf6-bc31-7799e98da70f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Quantum
• Version Model Number: 2783-245-5
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190707005993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973776

FDA Product Code

• DYW: BRACKET, PLASTIC, ORTHODONTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Quantum]

• 00190707006204: Quantum .018 UL1 12T 5A 0O
• 00190707006198: Quantum .018 UR1 12T 5A 0O
• 00190707006181: Quantum .022 UL1 12T 5A 0O
• 00190707006174: Quantum .022 UR1 12T 5A 0O
• 00190707006167: Quantum .018 LL/R5 -22T 0A 0O
• 00190707006150: Quantum .018 LL/R5 HK -22T
• 00190707006143: Quantum .022 LL/R5 -22T 0A 0O
• 00190707006136: Quantum .022 LL/R5 HK -22T
• 00190707006129: Quantum .018 LL/R4 -17T 0A 0O
• 00190707006112: Quantum .018 LL/R4 HK -17T
• 00190707006105: Quantum .022 LL/R4 -17T 0A 0O
• 00190707006099: Quantum .022 LL/R4 HK -17T
• 00190707006082: Quantum .018 LL3 -11T 5A 2O
• 00190707006075: Quantum .018 LR3 -11T 5A 2O
• 00190707006068: Quantum .018 LL3 HK -11T 5A 2O
• 00190707006051: Quantum .018 LR3 HK -11T 5A 2O
• 00190707006044: Quantum .022 LL3 -11T 5A 2O
• 00190707006037: Quantum .022 LR3 -11T 5A 2O
• 00190707006020: Quantum .022 LL3 HK -11T 5A 2O
• 00190707006013: Quantum .022 LR3 HK -11T 5A 2O
• 00190707006006: Quantum .018 UL/R 4/5 -7T
• 00190707005993: Quantum .018 UL/R 4/5 HK -7T
• 00190707005986: Quantum .022 UL/R 4/5 -7T
• 00190707005979: Quantum .022 UL/R 4/5 HK -7T
• 00190707005962: Quantum .018 UL3 0T 11A 4O
• 00190707005955: Quantum .018 UR3 0T 11A 4O
• 00190707005948: Quantum .018 UL3 HK 0T 11A 4O
• 00190707005931: Quantum .018 UR3 HK 0T 11A 4O
• 00190707005924: Quantum .022 UL3 0T 11A 4O
• 00190707005917: Quantum .022 UR3 0T 11A 4O
• 00190707005900: Quantum .022 UL3 HK 0T 11A 4O
• 00190707005894: Quantum .022 UR3 HK 0T 11A 4O
• 00190707005887: Quantum .018 UL2 8T 9A 0O
• 00190707005870: Quantum .018 UR2 8T 9A 0O
• 00190707005863: Quantum .022 UL2 8T 9A 0O
• 00190707005856: Quantum .022 UR2 8T 9A 0O
• 00190707005849: Quantum .018 LL/R 1/2 0T 0A 0O
• 00190707005832: Quantum .022 LL/R 1/2 0T 0A 0O
• 00190707005825: Quantum .022 Kit U/L 5x5 HKS
• 00190707005818: Quantum .018 Kit U/L 5x5 HKS
• 00190707005801: Quantum .022 Kit U/L 5x5
• 00190707005795: Quantum .018 Kit U/L 5x5