De Mayo Universal Distractor® - Loaner - De Mayo Universal Distractor® - Innovative Medical Products, Inc

Duns Number:147363154

Device Description: Loaner - De Mayo Universal Distractor®

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More Product Details

Catalog Number

907-LOANER

Brand Name

De Mayo Universal Distractor®

Version/Model Number

907-LOANER

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

FWZ

Product Code Name

Operating Room Accessories Table Tray

Device Record Status

Public Device Record Key

b938ea66-fdf4-4899-928b-6e64512fddb6

Public Version Date

November 01, 2019

Public Version Number

1

DI Record Publish Date

October 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOVATIVE MEDICAL PRODUCTS, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 518