Super Slick Stick Separators

GUDID 00192029039205

Super Slick

TP ORTHODONTICS INC

Birdshot retinochoroidopathy (BSRC) IVD, kit, nucleic acid technique (NAT)
Primary Device ID00192029039205
NIH Device Record Key0c05e56b-b1db-4594-b940-c6e154988c9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuper Slick Stick Separators
Version Model Number353-002
Company DUNS005432299
Company NameTP ORTHODONTICS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029039205 [Primary]

FDA Product Code

ECIBAND, ELASTIC, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

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00192029050552 - Tip-Edge PLUS Stainless Steel Brackets2025-02-12 UL LAT Torque +8, Tip +9
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00192029050576 - Tip-Edge PLUS Stainless Steel Brackets2025-02-12 UL CUS Torque -4, Tip +11
00192029050583 - Tip-Edge PLUS Stainless Steel Brackets2025-02-12 UR CUS Torque -4, Tip +11
00192029050590 - Tip-Edge PLUS Stainless Steel Brackets2025-02-12 UP BI CCW Torque -7, Tip 0
00192029050606 - Tip-Edge PLUS Stainless Steel Brackets2025-02-12 UP BI CW Torque -7, Tip 0

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