Elos Accurate® Prosthetic Screwdriver 26mm 68020508

GUDID 05712821013682

The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in different lengths. For specific product descriptions, please refer to individual product labels.

Elos Medtech Pinol A/S

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable
Primary Device ID05712821013682
NIH Device Record Key3894ae06-1717-4f6c-a01d-d7186d3b45b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameElos Accurate® Prosthetic Screwdriver 26mm
Version Model Number68020508
Catalog Number68020508
Company DUNS306155953
Company NameElos Medtech Pinol A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS105712821013682 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05712821013682]

Moist Heat or Steam Sterilization


[05712821013682]

Moist Heat or Steam Sterilization


[05712821013682]

Moist Heat or Steam Sterilization


[05712821013682]

Moist Heat or Steam Sterilization


[05712821013682]

Moist Heat or Steam Sterilization


[05712821013682]

Moist Heat or Steam Sterilization


[05712821013682]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-15
Device Publish Date2024-04-05

Devices Manufactured by Elos Medtech Pinol A/S

05712821013224 - X-Nav FastMap Scan Body2024-06-05 The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK).
05712821013231 - X-Nav FastMap Scan Body2024-06-05 The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK).
05712821013712 - Glidewell™ Torque Wrench2024-05-24 The Glidewell Torque Wrench is made of lightweight titanium and stainless steel. The Torque Wrench & Driver product design, fini
05712821013729 - Glidewell™ Torque Wrench2024-05-24 The Glidewell Torque Wrench is made of lightweight titanium and stainless steel. The Torque Wrench & Driver product design, fini
05712821012906 - High torque ISO Hex Adapter2024-05-23 A driver for a dental torque wrench for placement and adjustment of dental implants, abutments, abutment screw and prosthetic sc
05712821013606 - Elos Accurate® Scan Body 222024-05-15 The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding
05712821013613 - Elos Accurate® Scan Body 222024-05-15 The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding
05712821013620 - Elos Accurate® Scan Body 222024-05-15 The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding

Trademark Results [Elos Accurate]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ELOS ACCURATE
ELOS ACCURATE
86837307 5135482 Live/Registered
Elos Medtech AB
2015-12-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.