Envision

GUDID 00190707001452

Envision .022 Kit U/L 5x5 Roth HK

ORTHO ORGANIZERS, INC.

Orthodontic bracket, plastic, single-use

• Primary Device ID: 00190707001452
• NIH Device Record Key: a5bcedb1-7444-4203-8ac7-f4320475b119
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Envision
• Version Model Number: 701-198Q
• 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: true
• 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	00190707001452 [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 [Envision]

• 00190707001612: Envision .018 UL2 BIO 14T 9A 0O
• 00190707001605: Envision .018 UR2 BIO 14T 9A 0O
• 00190707001599: Envision .018 LL3 HK BIO 7T 5A 0O
• 00190707001582: Envision .018 LL3 BIO 7T 5A 0O
• 00190707001575: Envision .018 LR3 HK BIO 7T 5A 0O
• 00190707001568: Envision .018 LR3 BIO 7T 5A 0O
• 00190707001551: Envision .018 LL 1/2 BIO 0T 0A 0O
• 00190707001544: Envision .018 LR 1/2 BIO 0T 0A 0O
• 00190707001537: Envision .018 UL3 HK BIO 7T 5A 0O
• 00190707001520: Envision .018 UL3 BIO 7T 5A 0O
• 00190707001513: Envision .018 UR3 HK BIO 7T 5A 0O
• 00190707001506: Envision .018 UR3 BIO 7T 5A 0O
• 00190707001490: Envision .018 UL1 BIO 22T OA 0O
• 00190707001483: Envision .018 UR1 BIO 22T OA 0O
• 00190707001476: Envision .022 Kit U/L 5x5 Roth HKS
• 00190707001469: Envision .022 Kit U/L 5x5 MC HKS
• 00190707001452: Envision .022 Kit U/L 5x5 Roth HK
• 00190707001445: Envision .022 LL5 HK -22T 0A 0O
• 00190707001438: Envision .022 LR5 HK -22T 0A 0O
• 00190707001421: Envision .022 LL5 -22T 0A 0O
• 00190707001414: Envision .022 LR5 -22T 0A 0O
• 00190707001407: Envision .022 LL4 HK -17T 0A 0O
• 00190707001391: Envision .022 LR4 HK -17T 0A 0O
• 00190707001384: Envision .022 LL4 -17T 0A 0O
• 00190707001377: Envision .022 LR4 -17T 0A 0O
• 00190707001360: Envision .022 LL4 HK -12T 0A 0O
• 00190707001353: Envision .022 LL4 -12T 0A 0O
• 00190707001346: Envision .022 LR4 HK -12T 0A 0O
• 00190707001339: Envision .022 LR4 -12T 0A 0O
• 00190707001322: Envision .022 LL3 HK -6T 2A 0O
• 00190707001315: Envision .022 LL3 -6T 2A 0O
• 00190707001308: Envision .022 LR3 HK -6T 2A 0O
• 00190707001292: Envision .022 LR3 -6T 2A 0O
• 00190707001285: Envision .022 LL3 HK -11T 5A 0O
• 00190707001278: Envision .022 LR3 HK -11T 5A 0O
• 00190707001261: Envision .022 LL3 -11T 5A 0O
• 00190707001254: Envision .022 LR3 -11T 5A 0O
• 00190707001247: Envision .022 UL 4/5 HK -7T 0A 0O
• 00190707001230: Envision .022 UR 4/5 HK -7T 0A 0O
• 00190707001223: Envision .022 UL 4/5 -7T 0A 0O
• 00190707001216: Envision .022 UR 4/5 -7T 0A 0O
• 00190707001209: Envision .022 UL3 HK -7T 8A 0O
• 00190707001193: Envision .022 UL3 -7T 8A 0O
• 00190707001186: Envision .022 UR3 HK -7T 8A 0O
• 00190707001179: Envision .022 UR3 -7T 8A 0O
• 00190707001162: Envision .022 UL3 HK 0T 11A 0O
• 00190707001155: Envision .022 UR3 HK 0T 11A 0O
• 00190707001148: Envision .022 UL3 0T 11A 0O
• 00190707001131: Envision .022 UR3 0T 11A 0O
• 00190707001124: Envision .022 LL 1/2 0T 0A 0O