API 2/2 Kit 1 - KEELER LIMITED

Duns Number:210164398

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More Product Details

Catalog Number

-

Brand Name

API 2/2 Kit 1

Version/Model Number

1204-P-3100

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K854244

Product Code Details

Product Code

HLI

Product Code Name

Ophthalmoscope, Ac-Powered

Device Record Status

Public Device Record Key

11a2c419-5234-46a7-92df-78ed134277ef

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 16, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KEELER LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 158