POLOKOFF BONE RASPATORY - POLOKOFF BONE RASPATORY DOUBLE ENDED SINGLE-SIDED - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: POLOKOFF BONE RASPATORY DOUBLE ENDED SINGLE-SIDED TIP

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More Product Details

Catalog Number

1103-241

Brand Name

POLOKOFF BONE RASPATORY

Version/Model Number

1103-241

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

HTR

Product Code Name

RASP

Device Record Status

Public Device Record Key

19cc87e5-51df-40c4-8f0a-c88b88c468bc

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2018

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