FDA.report

ORTHOMETRIC SS

Primary DI
07898488902137
Brand
ORTHOMETRIC SS
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
52.50.2018
Catalog number
52.50.2018
Device description
ARCHWIRE STAINLESS STEEL SS ROUND 0,018" LOWER
Published
2022-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DZCWire, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07898488902137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07898488902137078984889021377898488902137

GMDN Terms

TermDefinition
Orthodontic archwireA dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods

Method

Regulatory Flags

DUNS number
898330003
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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07908611211934ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - TEAL GREEN60.05.70422025-12-22
07908611211941ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - EMERALD GREEN60.05.70432025-12-22
07908611211972ORTHOMETRIC ELASTIC CHAIN 4.5M - SHORT - TEAL GREEN60.05.51422025-12-22
07908611211989ORTHOMETRIC ELASTIC CHAIN 4.5M - SHORT - LIME GREEN60.05.51452025-12-22
07908611212054ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - ACQUA60.05.61412025-12-22
07908611212061ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - EMERALD GREEN60.05.61432025-12-22
07908611212085ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - NEON YELLOW60.05.61462025-12-22
07908611212092ORTHOMETRIC ELASTIC CHAIN 4.5M - MEDIUM - LIME GREEN60.05.61452025-12-22
07908611212122ORTHOMETRIC ELASTIC CHAIN 4.5M - LONG - ACQUA60.05.71412025-12-22
07908611212139ORTHOMETRIC ELASTIC CHAIN 4.5M - LONG - LIME GREEN60.05.71452025-12-22
07908611212207ORTHOMETRIC ELASTIC CHAIN 4.5M - LONG - NEON YELLOW60.05.71462025-12-22
07908611212740ORTHOMETRIC ELASTIC CHAIN 1.5M - SHORT - LIME GREEN60.05.50452025-12-22
07908611212757ORTHOMETRIC ELASTIC CHAIN 1.5M - SHORT - EMERALD GREEN60.05.50432025-12-22
07908611212795ORTHOMETRIC ELASTIC CHAIN 1.5M - MEDIUM - TEAL GREEN60.05.60422025-12-22
07908611212856ORTHOMETRIC ELASTIC CHAIN 1.5M - MEDIUM - LIME GREEN60.05.60452025-12-22
07908611212863ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - LIME GREEN60.05.70452025-12-22
07908611212887ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - NEON YELLOW60.05.70462025-12-22
07908611212894ORTHOMETRIC ELASTIC CHAIN 4.5M - SHORT - ACQUA60.05.51412025-12-22

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