Schaerer Medical USA - DISPOSABLE HEEL REST PAD (12 Pair) - Schaerer Medical Usa, Inc.

Duns Number:092820703

Device Description: DISPOSABLE HEEL REST PAD (12 Pair) DISPOSABLE HEEL REST PAD (12 Pair)

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More Product Details

Catalog Number

10379

Brand Name

Schaerer Medical USA

Version/Model Number

10379

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

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

FWZ

Product Code Name

Operating Room Accessories Table Tray

Device Record Status

Public Device Record Key

ead06022-91e9-44b0-913a-2ded14a12bb6

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 16, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCHAERER MEDICAL USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 110