FDA.report

Neoss Implant System

Primary DI
05060440332999
Brand
Neoss Implant System
Company
Neoss Ltd
Model
51178
Catalog number
51178
Device description
51178 Neoss® Guide - Guide Key Ø5.5
Published
2017-02-21
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060440332999PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060440332999050604403329995060440332999

GMDN Terms

TermDefinition
Fixture/appliance dental drill bit, single-useA sterile shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
999-999-9999contact.usa@neoss.com

Regulatory Flags

DUNS number
216693627
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

Other Devices From This Company

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05060440335860Neoss Implant SystemBridge Ti 2023-12-22
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05060440335181Neoss Implant System41177411772020-02-24
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05060440330926Neoss Implant System64010640102015-05-29
05060440330933Neoss Implant System64011640112015-05-29
05060440330940Neoss Implant System64012640122015-05-29
05060440330957Neoss Implant System64013640132015-05-29
05060440330964Neoss Implant System64014640142015-05-29
05060440331619Neoss Implant System64020640202015-08-26
05060440331626Neoss Implant System64021640212015-08-26
05060440334986Neoss Implant System51185511852020-01-27
05060440332661Neoss Implant System51150511502015-10-05
05060440332555Neoss Implant System51125511252015-10-05
05060440332081Neoss Implant System41178411782015-10-01
05060440332098Neoss Implant System41179411792015-10-01

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