Hydroxyapatite Orbital Implant - Porous Hydroxyapatite Orbital Implant, Sphere, - CERAMISYS LTD

Duns Number:423459374

Device Description: Porous Hydroxyapatite Orbital Implant, Sphere, 22mm

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More Product Details

Catalog Number

-

Brand Name

Hydroxyapatite Orbital Implant

Version/Model Number

SP22

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 20, 2021

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

K110554

Product Code Details

Product Code

HPZ

Product Code Name

Implant, Eye Sphere

Device Record Status

Public Device Record Key

61c31702-69a4-4eb8-8bfb-b090389e0f6c

Public Version Date

October 21, 2021

Public Version Number

4

DI Record Publish Date

July 31, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CERAMISYS LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 32