Alamo P - Multi-Tool Instrument - ALLIANCE PARTNERS LLC

Duns Number:962768169

Device Description: Multi-Tool Instrument

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More Product Details

Catalog Number

2100T-1905

Brand Name

Alamo P

Version/Model Number

2100T-1905

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

HWB

Product Code Name

EXTRACTOR

Device Record Status

Public Device Record Key

f4060e2f-f2a1-4655-b3ed-99dc26247313

Public Version Date

April 23, 2019

Public Version Number

5

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALLIANCE PARTNERS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 247
2 A medical device with a moderate to high risk that requires special controls. 291