AccuPort Side Delivery Cannula 11 Ga x 120mm - ZIMMER KNEE CREATIONS, INC.

Duns Number:078836317

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More Product Details

Catalog Number

307.032

Brand Name

AccuPort Side Delivery Cannula 11 Ga x 120mm

Version/Model Number

307.032

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

-

Product Code Details

Product Code

FGY

Product Code Name

Cannula, Injection

Device Record Status

Public Device Record Key

d18a15f4-6096-4602-8b60-ef7dd83a2c1d

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

May 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIMMER KNEE CREATIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 8