Ambler Surgical - Venus eye sphere, 10.0mm diameter, made of PMMA - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Venus eye sphere, 10.0mm diameter, made of PMMA plastic, packaged individually, sterile, d Venus eye sphere, 10.0mm diameter, made of PMMA plastic, packaged individually, sterile, disposable, box of 1

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More Product Details

Catalog Number

4129E

Brand Name

Ambler Surgical

Version/Model Number

4129E

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

4c1b48a4-020b-425e-a3c4-f03564a5b471

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMBLER SURGICAL CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14984
2 A medical device with a moderate to high risk that requires special controls. 3118