BioSphere Flex SP Extremities, Medium - BioSphere Flex SP Extremities, Medium - SYNERGY BIOMEDICAL, LLC

Duns Number:078270195

Device Description: BioSphere Flex SP Extremities, Medium

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More Product Details

Catalog Number

-

Brand Name

BioSphere Flex SP Extremities, Medium

Version/Model Number

BSF-00040

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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

K173424

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

4416dcb9-c42b-4443-a737-81b7339d2512

Public Version Date

June 09, 2021

Public Version Number

1

DI Record Publish Date

June 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNERGY BIOMEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16