Symmetry Surgical - OLSEN MEDICAL, LLC

Duns Number:079344210

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More Product Details

Catalog Number

e2401-52

Brand Name

Symmetry Surgical

Version/Model Number

e2401-52

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)

Yes

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

GBZ

Product Code Name

Catheter, Cholangiography

Device Record Status

Public Device Record Key

55d7878b-deb2-4e6d-a41f-a8fe0d0b6953

Public Version Date

November 19, 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

-

"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