B-P TOTAL HIP SYSTEM - B-P HIP FEMORAL HEAD W/ULTRACOAT - 32 MM + 10 MM - ENDOTEC, INC.

Duns Number:803488357

Device Description: B-P HIP FEMORAL HEAD W/ULTRACOAT - 32 MM + 10 MM

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More Product Details

Catalog Number

01-14-1032

Brand Name

B-P TOTAL HIP SYSTEM

Version/Model Number

01-14-1032

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

K892059

Product Code Details

Product Code

LZY

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal Ball

Device Record Status

Public Device Record Key

15eba88b-2540-49cc-b6a4-37a8c0859655

Public Version Date

September 09, 2020

Public Version Number

4

DI Record Publish Date

September 17, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENDOTEC, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 565