B-P TOTAL SHOULDER SYSTEM - B-P SHOULDER MODULAR SALVAGE HUMERAL STEM - ENDOTEC, INC.

Duns Number:803488357

Device Description: B-P SHOULDER MODULAR SALVAGE HUMERAL STEM W/BIOCOAT & W/ULTRACOAT - SIZE 1

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More Product Details

Catalog Number

02-21-0201

Brand Name

B-P TOTAL SHOULDER SYSTEM

Version/Model Number

02-21-0201

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

K982418

Product Code Details

Product Code

HSD

Product Code Name

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Device Record Status

Public Device Record Key

23d8af1f-667f-4be5-9a68-bf43fb58659e

Public Version Date

July 06, 2018

Public Version Number

3

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