Stealth Surgical - CUSHING IVD RONGEUR, 1.5MM X 10MM, 9", UP - BOSS INSTRUMENTS, LTD., INC.

Duns Number:848522678

Device Description: CUSHING IVD RONGEUR, 1.5MM X 10MM, 9", UP

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More Product Details

Catalog Number

SS7275

Brand Name

Stealth Surgical

Version/Model Number

SS7275

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)

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

HAE

Product Code Name

RONGEUR, MANUAL

Device Record Status

Public Device Record Key

7acaad2b-6467-40ac-b711-1547b0650551

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

October 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BOSS INSTRUMENTS, LTD., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 3026