Catalog Number

-

Brand Name

MectaTap

Version/Model Number

05.10.013

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

K191677

Product Code

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Public Device Record Key

ec9c17b4-c648-4e8a-83f3-ede2ce2eae0a

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

February 03, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-