ACUMED - 120mm Tension Band Kit - Acumed LLC

Duns Number:196884852

Device Description: 120mm Tension Band Kit

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More Product Details

Catalog Number

-

Brand Name

ACUMED

Version/Model Number

TB-15120K-S

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

Yes

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

K964500

Product Code Details

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Device Record Status

Public Device Record Key

e8fc8a3c-bbf6-4b8b-99df-abc895e6b31d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACUMED LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1870
2 A medical device with a moderate to high risk that requires special controls. 4532