FDA.report

TrollFoil

Primary DI
17310230000788
Brand
TrollFoil
Company
Directa AB
Model
4,5 blue
Catalog number
12000145
Published
2022-12-06
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
EFHPaper, Articulation

Product Code Classifications

CodeDeviceSpecialtyClass
EFHPaper, ArticulationDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
17310230000788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1731023000078817310230000788

GMDN Terms

TermDefinition
Dental articulatorA hinged, mechanical, dental device designed to simulate the movement of a patient's upper and lower jaws and onto which maxillary and mandibular casts or models are attached according to a pre-recorded intermaxillary relationship. It is designed to simulate all or part of the mandibular movements and is used for, e.g., examination, diagnosis, or to construct dental appliances. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
353954381
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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