Boss Instruments - Takahashi Nasal Fcps, 3x10mm jaw - BOSS INSTRUMENTS, LTD., INC.

Duns Number:848522678

Device Description: Takahashi Nasal Fcps, 3x10mm jaw

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More Product Details

Catalog Number

93-1152

Brand Name

Boss Instruments

Version/Model Number

93-1152

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

a1ff569a-74c9-4cfe-840b-743f401c17aa

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

September 20, 2018

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