Ambler Surgical - Mendez corneal LASIK marker, to identify and - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Mendez corneal LASIK marker, to identify and realign the lamellar flap, flat handle

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More Product Details

Catalog Number

8720E

Brand Name

Ambler Surgical

Version/Model Number

Mendez corneal LASIK marker

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

-

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

HMR

Product Code Name

Marker, ocular

Device Record Status

Public Device Record Key

b76f89c4-300e-4c5e-b64c-c16ad27cae96

Public Version Date

January 12, 2021

Public Version Number

1

DI Record Publish Date

January 04, 2021

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