SmileGoods Aligner Removers 71098114

GUDID 00723896021866

Single packed plastic clear aligner removers. Assorted Colors. 48 pieces in a box

PRACTICON, INC.

Orthodontic appliance remover
Primary Device ID00723896021866
NIH Device Record Key6b3a2807-c0f8-495d-b282-3edb8ef1fa8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmileGoods Aligner Removers
Version Model Number71098114
Catalog Number71098114
Company DUNS119193803
Company NamePRACTICON, 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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100723896021859 [Primary]
GS100723896021866 [Package]
Contains: 00723896021859
Package: case [20 Units]
In Commercial Distribution

FDA Product Code

ECQAligner, Bracket, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-15
Device Publish Date2022-11-07

Devices Manufactured by PRACTICON, INC.

00723896025994 - SMILEGOODS 3 IN 1 FLOSSERS2024-08-15 Flosser that combines a flosser, pick, and interdental brush. Individually wrapped. 500 per pack.
00723896026342 - 2.75" X 10" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026373 - 3.5" X 6.5" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026403 - 3.5" X 10" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026434 - 5.25" X 11" PRACTICON STERILIZATION POUCHES2024-08-15 Self-Sealing sterilization pouches with internal and external indicators. 200 per box
00723896026632 - PRACTIFILM BARRIER FILM BLUE2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role
00723896026663 - PRACTIFILM BARRIER FILM BLACK2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role
00723896026694 - PRACTIFILM BARRIER FILM CLEAR2024-08-15 4" x 6" 1.5 mil polyethylene cling sheets that act as a barrier for contamination control. 1200 per role

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