Innomed, Inc. - Pin Driver with A/O Tripan - INNOMED, INC.

Duns Number:878427491

Device Description: Pin Driver with A/O Tripan

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More Product Details

Catalog Number

1205-MOD

Brand Name

Innomed, Inc.

Version/Model Number

1205-MOD

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

-

Product Code Details

Product Code

HXX

Product Code Name

Screwdriver

Device Record Status

Public Device Record Key

d5a43868-79df-43d3-b232-88862136cdf2

Public Version Date

November 08, 2021

Public Version Number

1

DI Record Publish Date

October 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2683
2 A medical device with a moderate to high risk that requires special controls. 14