Catalog Number

72205136

Brand Name

HEALICOIL

Version/Model Number

72205136

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K193558

Product Code

MAI

Product Code Name

Fastener, fixation, biodegradable, soft tissue

Public Device Record Key

96914114-9e63-439e-a21d-bf4f93de6660

Public Version Date

August 26, 2020

Public Version Number

1

DI Record Publish Date

August 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-