CirFIX® Cranial bone fixation system: Flap Fixator - CUSMED Flap Fixator, Low Profile Replaceable - OSSAWARE BIOTECH CO., LTD.

Duns Number:656747172

Device Description: CUSMED Flap Fixator, Low Profile Replaceable Type+Screwdriver, PEEK, D15mm, Sterile

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More Product Details

Catalog Number

9903.0001.15S

Brand Name

CirFIX® Cranial bone fixation system: Flap Fixator

Version/Model Number

9903.0001.15S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

Yes

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

K192310,K192310,K192310

Product Code Details

Product Code

GXR

Product Code Name

Cover, Burr Hole

Device Record Status

Public Device Record Key

d92a5041-42a6-4364-a215-a873cedba602

Public Version Date

July 22, 2021

Public Version Number

4

DI Record Publish Date

September 28, 2020

Additional Identifiers

Package DI Number

14717002404165

Quantity per Package

8

Contains DI Package

04717002404168

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Delivery box