Pedicle Screw - MPS Screw Shank, Dual Lead, 7.5 x 65mm - Eisertech, LLC

Duns Number:965627297

Device Description: MPS Screw Shank, Dual Lead, 7.5 x 65mm

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More Product Details

Catalog Number

100320-7565D

Brand Name

Pedicle Screw

Version/Model Number

100320-7565D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

-

Product Code Details

Product Code

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

506a5582-a748-4a37-8e71-e65c00c99dc9

Public Version Date

August 27, 2019

Public Version Number

1

DI Record Publish Date

August 19, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EISERTECH, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 459