Sterilization Tray Em Cranial / Ent Instruments - Brainlab AG

Duns Number:314482980

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More Product Details

Catalog Number

18099-07A

Brand Name

Sterilization Tray Em Cranial / Ent Instruments

Version/Model Number

18099-07A

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)

-

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

04b2234d-72d8-475d-a9a7-8bf7c38a8ab0

Public Version Date

July 08, 2021

Public Version Number

5

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BRAINLAB AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 48
2 A medical device with a moderate to high risk that requires special controls. 685