OPERON - Surgical Table Pad, 3 Inch Back - STRYKER COMMUNICATIONS INC.

Duns Number:078807493

Device Description: Surgical Table Pad, 3 Inch Back

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More Product Details

Catalog Number

OZ 7551075

Brand Name

OPERON

Version/Model Number

OZ 7551075

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)

Yes

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

LWG

Product Code Name

SURGICAL TABLE CUSHION

Device Record Status

Public Device Record Key

953690fd-9c13-4c6f-9e40-66f09b257f5d

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

January 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER COMMUNICATIONS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 44
2 A medical device with a moderate to high risk that requires special controls. 9