Inion BioRestore™ - Block 5 x 10 x 4 mm - Inion Oy

Duns Number:367994657

Device Description: Block 5 x 10 x 4 mm

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More Product Details

Catalog Number

BRS-5440

Brand Name

Inion BioRestore™

Version/Model Number

1

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

-

Product Code Details

Product Code

MQV

Product Code Name

FILLER, BONE VOID, CALCIUM COMPOUND

Device Record Status

Public Device Record Key

69f0facd-8ede-4611-b98b-fa2905a55222

Public Version Date

March 11, 2020

Public Version Number

1

DI Record Publish Date

March 03, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INION OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 201
2 A medical device with a moderate to high risk that requires special controls. 473