EIT ALIF Paddle Distractor - Paddle Distractor, H 8mm - EIT Emerging Implant Technologies GmbH

Duns Number:313088331

Device Description: Paddle Distractor, H 8mm

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More Product Details

Catalog Number

-

Brand Name

EIT ALIF Paddle Distractor

Version/Model Number

AET10208

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

K170503

Product Code Details

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

3c67465f-1f47-4ff3-bdaa-853c2cf95ac8

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 09, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EIT EMERGING IMPLANT TECHNOLOGIES GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 234
2 A medical device with a moderate to high risk that requires special controls. 1726