EndoPilot Motor - EndoPilot Motor with ISO-E standard; - Schlumbohm GmbH & Co. KG

Duns Number:343831731

Device Description: EndoPilot Motor with ISO-E standard; LED-indicator and Apex-contact

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More Product Details

Catalog Number

109 0112

Brand Name

EndoPilot Motor

Version/Model Number

EDP2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K202906

Product Code Details

Product Code

EKX

Product Code Name

Handpiece, Direct Drive, Ac-Powered

Device Record Status

Public Device Record Key

2e965434-ab51-49c3-9b2b-b55eb2f22ef8

Public Version Date

June 10, 2021

Public Version Number

1

DI Record Publish Date

June 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCHLUMBOHM GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 6