Innomed, Inc. - Delrin Head Replacement with 0.875" Stud Single - INNOMED, INC.

Duns Number:878427491

Device Description: Delrin Head Replacement with 0.875" Stud Single

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More Product Details

Catalog Number

7832-Head03

Brand Name

Innomed, Inc.

Version/Model Number

7832-Head03

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

FZY

Product Code Name

Hammer, Surgical

Device Record Status

Public Device Record Key

60a4fdf2-0ff2-467b-8724-9a0ec289edc9

Public Version Date

February 18, 2020

Public Version Number

1

DI Record Publish Date

February 10, 2020

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