FDA.report

Neodent

Primary DI
07899878046882
Brand
Neodent
Company
JJGC Indústria e Comércio de Materiais Dentários S/A.
Model
105161
Catalog number
105161
Device description
NGS GM NARROW DRIVER FOR CONTRA-ANGLE
Published
2021-04-27
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
false

Related Records

Contact Domains

Product Codes

CodeName
EIFACCESSORIES, RETRACTOR, DENTAL
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899878046882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899878046882078998780468827899878046882

GMDN Terms

TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Device Sizes

TypeValueUnit
Outer Diameter1.2Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Protect from Sunlight
Special Storage Condition, Specify00Room temperature.
Storage Environment Temperature040 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(855)412-8883customerservice.us@instradent.com

Regulatory Flags

DUNS number
906713888
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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