Ambler Surgical - Paparella fenestrometer, 6 1/2'', malleable, - AMBLER SURGICAL CORP.

Duns Number:015272206

Device Description: Paparella fenestrometer, 6 1/2'', malleable, straight shaft, straight, 1mm wide x 4.0mm lo Paparella fenestrometer, 6 1/2'', malleable, straight shaft, straight, 1mm wide x 4.0mm long scale, measures in 0.5mm and 1.0mm increments, hexagonal handle

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More Product Details

Catalog Number

14-160

Brand Name

Ambler Surgical

Version/Model Number

Paparella fenestrometer

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

JYJ

Product Code Name

GAUGE, MEASURING

Device Record Status

Public Device Record Key

5a44bc85-94e2-4d1c-99ad-fd614832cdea

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