ATR+ - ATR+ SMALL WEDGE - 2 PK - EHOB INC

Duns Number:150600252

Device Description: ATR+ SMALL WEDGE - 2 PK

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More Product Details

Catalog Number

PPATRPSMWDG2

Brand Name

ATR+

Version/Model Number

REV00

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

FMR

Product Code Name

Device, Transfer, Patient, Manual

Device Record Status

Public Device Record Key

c374db0d-4560-4cc0-b89b-c78249b4b6f2

Public Version Date

July 26, 2022

Public Version Number

1

DI Record Publish Date

July 18, 2022

Additional Identifiers

Package DI Number

30603354120656

Quantity per Package

3

Contains DI Package

10603354120645

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"EHOB INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 132