De Mayo Universal Distractor® - Sterile Pressure Protector Pad® for De Mayo - Innovative Medical Products, Inc

Duns Number:147363154

Device Description: Sterile Pressure Protector Pad® for De Mayo Universal Distractor® (10/case)

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More Product Details

Catalog Number

907-GP-10

Brand Name

De Mayo Universal Distractor®

Version/Model Number

907-GP-10

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"

Yes

For Single-Use

Yes

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

FMP

Product Code Name

Protector, Skin Pressure

Device Record Status

Public Device Record Key

94498cbe-f691-4cb6-a63a-c013a56f8f98

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

September 25, 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