Symmetry Surgical - OLSEN MEDICAL, LLC

Duns Number:079344210

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More Product Details

Catalog Number

e2504-01

Brand Name

Symmetry Surgical

Version/Model Number

e2504-01

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

GAD

Product Code Name

Retractor

Device Record Status

Public Device Record Key

e4680693-afcd-4ecc-b237-4408cdbf5f8e

Public Version Date

August 21, 2019

Public Version Number

2

DI Record Publish Date

July 02, 2019

Additional Identifiers

Package DI Number

30841785113384

Quantity per Package

4

Contains DI Package

00841785113383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OLSEN MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 1233