A/R Screw 3.2mm Sleeve - Zimmer, Inc.

Duns Number:056038268

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More Product Details

Catalog Number

SSI006172

Brand Name

A/R Screw 3.2mm Sleeve

Version/Model Number

SSI006172

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)

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

HWD

Product Code Name

Starter, Bone Screw

Device Record Status

Public Device Record Key

6842f7d2-6a44-48ea-b33d-d63e4b3d2b23

Public Version Date

January 15, 2021

Public Version Number

1

DI Record Publish Date

January 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIMMER, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8464
2 A medical device with a moderate to high risk that requires special controls. 20880
3 A medical device with high risk that requires premarket approval 133