PEDIGUARD THREADED - SPINEGUARD

Duns Number:260589566

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More Product Details

Catalog Number

D1ST0001

Brand Name

PEDIGUARD THREADED

Version/Model Number

DSG Sleeve #1

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)

-

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

FZX

Product Code Name

Guide, Surgical, Instrument

Device Record Status

Public Device Record Key

105e4c88-2baf-49f0-8b06-d2527809a6c7

Public Version Date

November 22, 2018

Public Version Number

1

DI Record Publish Date

October 22, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINEGUARD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13
2 A medical device with a moderate to high risk that requires special controls. 26