Pocket Pal II™ - Pocket Pal II Kit,White, Disp pkg - AMERICAN DIAGNOSTIC CORP

Duns Number:108999095

Device Description: Pocket Pal II Kit,White, Disp pkg

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More Product Details

Catalog Number

116WQ

Brand Name

Pocket Pal II™

Version/Model Number

116WQ

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRW

Product Code Name

Scissors, General, Surgical

Device Record Status

Public Device Record Key

a1c29a74-4866-446b-8aff-6e7851ff95a1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

00634782564834

Quantity per Package

36

Contains DI Package

00634782065164

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case

"AMERICAN DIAGNOSTIC CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2395
2 A medical device with a moderate to high risk that requires special controls. 1769