Retro Nail Depth Gauge +5cm - Zimmer, Inc.

Duns Number:056038268

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More Product Details

Catalog Number

SSI006705

Brand Name

Retro Nail Depth Gauge +5cm

Version/Model Number

SSI006705

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

K101622

Product Code Details

Product Code

KWS

Product Code Name

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Device Record Status

Public Device Record Key

aaa613f7-9922-4c8f-bba8-884e183a92de

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 06, 2022

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