FDA.report

ORTHOMETRIC FLEY NITI SPRINGS

Primary DI
07908470707104
Brand
ORTHOMETRIC FLEY NITI SPRINGS
Company
ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA
Model
35.21.0015
Catalog number
35.21.0015
Device description
WIRE FLEXY NITI- CLOSE SPRING FOR MINI SCREW 15MM
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
ECOSpring, Orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
ECOSpring, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07908470707104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07908470707104079084707071047908470707104

GMDN Terms

TermDefinition
Orthodontic springA dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. This is a single-patient device that is 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07908611211880ORTHOMETRIC ELASTIC CHAIN 1.5M - SHORT - GREEN60.05.50442025-12-22
07908611211927ORTHOMETRIC ELASTIC CHAIN 1.5M - LONG - GREEN60.05.70442025-12-22
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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