FDA.report

Directa FullForm

Primary DI
17310236098567
Brand
Directa FullForm
Company
Directa AB
Model
OP R171
Catalog number
609856
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
ELZCrown, Preformed

Product Code Classifications

CodeDeviceSpecialtyClass
ELZCrown, PreformedDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
17310236098567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1731023609856717310236098567

GMDN Terms

TermDefinition
Dental mouldA hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.

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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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