Alamo P, Alamo T - Paddle Shaver Instrument - ALLIANCE PARTNERS LLC

Duns Number:962768169

Device Description: Paddle Shaver Instrument

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More Product Details

Catalog Number

2100T-1608

Brand Name

Alamo P, Alamo T

Version/Model Number

2100T-1608

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

K120401,K122047,K140303

Product Code Details

Product Code

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Record Status

Public Device Record Key

b9e710a4-e375-4bc9-961d-0bce3fd839b4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 01, 2017

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