FDA.report

Nobel Biocare®

Primary DI
07332747006018
Brand
Nobel Biocare®
Company
Nobel Biocare AB
Model
32848
Catalog number
32848
Device description
Guided Dense Bone Drill Tapered RP 4.3x16mm
Published
2016-09-17
Public version status
Update
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
DZIDRILL, BONE, POWERED
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07332747006018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07332747006018073327470060187332747006018

GMDN Terms

TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes

TypeValueUnit
Length16Millimeter
Outer Diameter4.3Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep dry

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)322-5001us.customerservice@nobelbiocare.com

Regulatory Flags

DUNS number
353939929
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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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