Orbital sphere implant - An implantable ocular device designed to - FCI S A S FCI 20 22

Duns Number:763408366

Device Description: An implantable ocular device designed to permanently fill the orbital cavity following enu

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More Product Details

Catalog Number

S6.5116U

Brand Name

Orbital sphere implant

Version/Model Number

BIOCERAMIC ORBITAL IMPLANT Ø 16 mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

-

Product Code Details

Product Code

HPZ

Product Code Name

Implant, Eye Sphere

Device Record Status

Public Device Record Key

6496dcf3-aa67-4a17-ba4d-f54f3fa198ed

Public Version Date

March 16, 2020

Public Version Number

1

DI Record Publish Date

March 06, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FCI S A S FCI 20 22" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 291
U Unclassified 60