Carousel Ligature Dispenser

GUDID 00192029039489

Standard Multi-Color

TP ORTHODONTICS INC

Orthodontic archwire/bracket ligature Orthodontic archwire/bracket ligature Orthodontic archwire/bracket ligature Orthodontic archwire/bracket ligature Orthodontic archwire/bracket ligature Orthodontic archwire/bracket ligature Orthodontic archwire/bracket ligature Orthodontic archwire/bracket ligature Orthodontic archwire/bracket ligature Orthodontic archwire/bracket ligature Orthodontic archwire/bracket ligature Orthodontic archwire/bracket ligature
Primary Device ID00192029039489
NIH Device Record Keycc1a936c-a308-44b8-bacf-c2f152ca7c50
Commercial Distribution StatusIn Commercial Distribution
Brand NameCarousel Ligature Dispenser
Version Model Number361-099
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
GS100192029039489 [Primary]
GS100192029039489 [Primary]
GS100192029039489 [Primary]
GS100192029039489 [Primary]
GS100192029039489 [Primary]
GS100192029039489 [Primary]
GS100192029039489 [Primary]
GS100192029039489 [Primary]
GS100192029039489 [Primary]
GS100192029039489 [Primary]
GS100192029039489 [Primary]
GS100192029039489 [Primary]

FDA Product Code

ECIBAND, ELASTIC, ORTHODONTIC
ECIBAND, ELASTIC, ORTHODONTIC
ECIBAND, ELASTIC, ORTHODONTIC
ECIBAND, ELASTIC, ORTHODONTIC
ECIBAND, ELASTIC, ORTHODONTIC
ECIBAND, ELASTIC, ORTHODONTIC
ECIBAND, ELASTIC, ORTHODONTIC
ECIBAND, ELASTIC, ORTHODONTIC
ECIBAND, ELASTIC, ORTHODONTIC
ECIBAND, ELASTIC, ORTHODONTIC
ECIBAND, ELASTIC, ORTHODONTIC
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 [Carousel Ligature Dispenser]

00192029039991Super Slick Multi-Color
00192029039984Super Slick Silver-Grey & Clear
00192029039489Standard Multi-Color
00192029039472Standard Silver-Grey & Clear

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.