CLEAR FLUSH - STAINLESS STEEL KERRISON RONGEUR 11" 5MM BITE 40 - ADVANCED INSTRUMENTATION FOR MEDICINE,INC.

Duns Number:080478537

Device Description: STAINLESS STEEL KERRISON RONGEUR 11" 5MM BITE 40 DEGREE

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More Product Details

Catalog Number

-

Brand Name

CLEAR FLUSH

Version/Model Number

SS11-5MM40

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 20, 2018

Issuing Agency

In HIBCC

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

HAE

Product Code Name

Rongeur, Manual

Device Record Status

Public Device Record Key

7d9a2070-99f4-499e-a5aa-34f5e4842733

Public Version Date

July 12, 2019

Public Version Number

4

DI Record Publish Date

January 17, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED INSTRUMENTATION FOR MEDICINE,INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 181