Sutter - Storage and instrument tray ORL Set - Sutter Medizintechnik GmbH

Duns Number:316625425

Device Description: Storage and instrument tray ORL Set Marinescu for Standa Storage and instrument tray ORL Set Marinescu for Standard Container

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More Product Details

Catalog Number

701746

Brand Name

Sutter

Version/Model Number

701746

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Unsafe

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

-

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

dfef7dfa-9dcd-41a6-beb3-597604b34d02

Public Version Date

September 16, 2022

Public Version Number

9

DI Record Publish Date

December 13, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUTTER MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 265