NeoCrystal Plus

GUDID 00190707006372

NeoCrystal Plus .018 UL 4/5 -7T 0A

ORTHO ORGANIZERS, INC.

Orthodontic bracket, ceramic
Primary Device ID00190707006372
NIH Device Record Keydef00b09-1ddf-42b5-8a84-f9284d07fdac
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoCrystal Plus
Version Model Number715-258-5
Company DUNS062165188
Company NameORTHO ORGANIZERS, INC.
Device Count1
DM Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190707006372 [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 Date2018-03-29
Device Publish Date2016-09-24

On-Brand Devices [NeoCrystal Plus]

00190707007126NeoCrystal Plus .022 Kit U/L 5x5 Roth HKS
00190707007119NeoCrystal Plus .022 Kit U/L 5x5 MC (0T) HKS
00190707007102NeoCrystal Plus .022 Kit U/L 5x5 Roth HK
00190707007096NeoCrystal Plus .022 Kit U/L 5x5 MC (0T) HK
00190707007089NeoCrystal Plus .022 LL5 HK -21T 0A
00190707007072NeoCrystal Plus .022 LL5 -21T 0A
00190707007065NeoCrystal Plus .022 LR5 HK -21T 0A
00190707007058NeoCrystal Plus .022 LR5 -21T 0A
00190707007041NeoCrystal Plus .022 LL5 -17T 2A
00190707007034NeoCrystal Plus .022 LL5 -17T 2A
00190707007027NeoCrystal Plus .022 LR5 HK -17T 2A
00190707007010NeoCrystal Plus .022 LR5 -17T 2A
00190707007003NeoCrystal Plus .022 LL4 HK -17T 0A
00190707006990NeoCrystal Plus .022 LL4 -17T 0A
00190707006983NeoCrystal Plus .022 LR4 HK -17T 0A
00190707006976NeoCrystal Plus .022 LR4 -17T 0A
00190707006969NeoCrystal Plus .022 LL4 HK -12T 2A
00190707006952NeoCrystal Plus .022 LL4 -12T 2A
00190707006945NeoCrystal Plus .022 LR4 -12T 2A
00190707006938NeoCrystal Plus .022 LR4 -12T 2A
00190707006921NeoCrystal Plus .022 LL3 HK 0T 3A
00190707006914NeoCrystal Plus .022 LR3 HK 0T 3A
00190707006907NeoCrystal Plus .022 LL3 HK -11T 7A
00190707006891NeoCrystal Plus .022 LR3 HK -11T 7A
00190707006884NeoCrystal Plus .022 UL 4/5 HK -7T 0A
00190707006877NeoCrystal Plus .022 UL 4/5 -7T 0A
00190707006860NeoCrystal Plus .022 UR 4/5 HK -7T 0A
00190707006853NeoCrystal Plus .022 UR 4/5 -7T 0A
00190707006846NeoCrystal Plus .022 UL 4/5 HK -7T 0A
00190707006839NeoCrystal Plus .022 UL 4/5 -7T 0A
00190707006822NeoCrystal Plus .022 UR 4/5HK -7T 0A
00190707006815NeoCrystal Plus .022 UR 4/5 -7T 0A
00190707006808NeoCrystal Plus .022 UL3 HK - 0T 8A
00190707006792NeoCrystal Plus .022 UR3 HK - 0T 8A
00190707006785NeoCrystal Plus .022 UL3 HK -2T 8A
00190707006778NeoCrystal Plus .022 UR3 HK -2T 8A
00190707006761NeoCrystal Plus .022 LL/R 1/2 -6T 0A
00190707006754NeoCrystal Plus .022 LL/R 1/2 0T 0A
00190707006747NeoCrystal Plus .022 UL2 10T 8A
00190707006730NeoCrystal Plus .022 UR2 10T 8A
00190707006723NeoCrystal Plus .022 UL2 8T 9A
00190707006716NeoCrystal Plus .022 UR2 8T 9A
00190707006709NeoCrystal Plus .022 UL1 17T 4A
00190707006693NeoCrystal Plus .022 UR1 17T 4A
00190707006686NeoCrystal Plus .022 UL1 11T 5A
00190707006679NeoCrystal Plus .022 UR1 11T 5A
00190707006662NeoCrystal Plus .018 Kit U/L 5x5 Roth HKS
00190707006655NeoCrystal Plus .018 Kit U/L 5x5 MC (0T) HKS
00190707006648NeoCrystal Plus .018 Kit U/L 5x5 Roth HK
00190707006631NeoCrystal Plus .018 Kit U/L 5x5 MC (0T) HK
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