SU-POR Surgical Implant - Quadro-Port Tunnel Orbital Sphere 16mm w - PORIFEROUS, LLC

Duns Number:078388975

Device Description: Quadro-Port Tunnel Orbital Sphere 16mm w Enucleation Introducer

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More Product Details

Catalog Number

4036

Brand Name

SU-POR Surgical Implant

Version/Model Number

4036

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

K140437

Product Code Details

Product Code

FWP

Product Code Name

Prosthesis, Chin, Internal

Device Record Status

Public Device Record Key

3e5ea6e4-93c7-426e-b116-a46c1843b7c7

Public Version Date

September 29, 2021

Public Version Number

1

DI Record Publish Date

September 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PORIFEROUS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 318