FDA.report

DYNAMIC ABUTMENT® SOLUTIONS

Primary DI
08435673500885
Brand
DYNAMIC ABUTMENT® SOLUTIONS
Company
TALLADIUM ESPAÑA SL
Model
49.604.000.08-2
Device description
Wrench adaptor comp.Nobel Biocare
Published
2022-04-19
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
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08435673500885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08435673500885084356735008858435673500885

GMDN Terms

TermDefinition
Surgical torque wrench adaptorA component of a surgical wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a variety of distal end pieces (bits). It is intended to be used during an invasive surgical procedure, and is not dedicated to dental use only. It may be referred to as a driver. This is a reusable device intended to be sterilized prior to use.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+34973289580das@dynamicabutment.com

Regulatory Flags

DUNS number
510591266
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
true

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