CASPAR CERVICAL STANDARD BLADE - CASPAR CERVICAL STANDARD BLADE SET OF 2 - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: CASPAR CERVICAL STANDARD BLADE SET OF 2

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More Product Details

Catalog Number

-

Brand Name

CASPAR CERVICAL STANDARD BLADE

Version/Model Number

416-203

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 22, 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

FFO

Product Code Name

Retractor, Self-Retaining

Device Record Status

Public Device Record Key

8ec1e42b-cb0a-491c-9d8b-db9d33976871

Public Version Date

May 10, 2021

Public Version Number

9

DI Record Publish Date

August 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414