ELASTOMERIC CHAIN ORTHOMETRIC - 4,5M - MEDIUM - MARSALA

GUDID 07908611210609

ELASTOMERIC CHAIN ORTHOMETRIC - 4,5M - MEDIUM - MARSALA

ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

Orthodontic inter-arch elastic band
Primary Device ID07908611210609
NIH Device Record Key47ec580b-efa3-4500-a3f6-68e50ab9eb1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameELASTOMERIC CHAIN ORTHOMETRIC - 4,5M - MEDIUM - MARSALA
Version Model Number60.05.6158
Company DUNS898330003
Company NameORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107908611210609 [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 Date2025-04-10
Device Publish Date2025-04-02

Devices Manufactured by ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA

07908611210333 - ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULAR2025-04-15 1 SET ICERAM-P MBT 0.022 1 PAIR OF ESTHETIC ARCHWIRES 1 PEARL BLUE MODULAR
07908611210340 - ICERAM-P MBT 0.022 KIT – 5 SETS + 1 FREE MIXED ORTHODONTIC MANNEQUIN2025-04-15 ICERAM-P MBT 0.022 5 SETS 1 FREE MIXED ORTHODONTIC MANNEQUIM
07908611211163 - PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR 2025-04-15 PREMIUM ELITE KIT ROTH 0.022 – 1 SET 4 TUBES 1 PAIR OF ARCHEWIRE 1 MODULAR LIGATURE
07908611211170 - PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR2025-04-15 PREMIUM ELITE KIT MBT 0.022 1 SET 4 TUBES 1 PAIR OF ARCHWIRES 1 MODULAR LIGATURE
07908611211200 - BUTTON WITH HOOK MJANSON2025-04-15 BUTTON WITH HOOK BONDING MJANSON
07908611211217 - ORTHODONTIC POWER ARM BUTTON FOR BONDING MJANSON – DISK HOOK2025-04-15 ORTHODONTIC POWER ARM BUTTON FOR BONDING MJANSON – DISK HOOK
07908611211224 - ORTHODONTIC POWER ARM BUTTON FOR CRIMPING MJANSON – DISK HOOK2025-04-15 ORTHODONTIC POWER ARM BUTTON FOR CRIMPING MJANSON – DISK HOOK
07908611204257 - ORTHOCHEWIE BITER FOR ALIGNERS W/ 03 UN2025-04-11 ORTHOCHEWIE BITER FOR ALIGNERS W/ 03 UN

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