Super Slick E Chain

GUDID 00192029040553

Grey Large

TP ORTHODONTICS INC

Birdshot retinochoroidopathy (BSRC) IVD, kit, nucleic acid technique (NAT)
Primary Device ID00192029040553
NIH Device Record Keyd5c0eb5c-fcf0-40f8-ae8a-5ab7ce0d2018
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuper Slick E Chain
Version Model Number390-249
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
GS100192029040553 [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

On-Brand Devices [Super Slick E Chain]

00192029040584Grey Mini
00192029040577Clear Mini
00192029040560Clear Large
00192029040553Grey Large
00192029040546Clear Medium
00192029040539Grey Medium
00192029040522Clear Small
00192029040515Grey Small

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