Catalog Number

US99U100052

Brand Name

Symbios ™

Version/Model Number

PepGen P-15 Flow

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 01, 2015

Issuing Agency

In HIBCC

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"

Yes

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

-

Product Code

NPZ

Product Code Name

Bone grafting material, dental, with biologic component

Public Device Record Key

23dc0199-1f29-436d-a1e1-4615cf5f0ac4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 02, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-