PIP - PIP Trial Pack: 30ea 903; 10ea 901; 10ea 902 - AMITY HOLDINGS, LLC

Duns Number:016069284

Device Description: PIP Trial Pack: 30ea 903; 10ea 901; 10ea 902

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More Product Details

Catalog Number

903TP

Brand Name

PIP

Version/Model Number

903TP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

October 14, 2025

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

Yes

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

4d8d46c5-6599-49f4-96dc-402bf70ff6bb

Public Version Date

October 22, 2020

Public Version Number

1

DI Record Publish Date

October 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMITY HOLDINGS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 5