Ambler Surgical - Koch-Mendez degree gauge, 4'', beveled face, - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Koch-Mendez degree gauge, 4'', beveled face, 11.7mm internal diameter, measures 0-180 degr Koch-Mendez degree gauge, 4'', beveled face, 11.7mm internal diameter, measures 0-180 degrees in 5 degrees increments, ring mounted at 135 degrees, 36 point fixation, round handle

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More Product Details

Catalog Number

8890E

Brand Name

Ambler Surgical

Version/Model Number

Koch-Mendez degree gauge

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

HNH

Product Code Name

RING, OPHTHALMIC (FLIERINGA)

Device Record Status

Public Device Record Key

49578f91-d353-4f5e-b5a1-3d3377dd56cd

Public Version Date

January 15, 2021

Public Version Number

1

DI Record Publish Date

January 07, 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