Shoulder Innovations Inset Reverse Total Shoulder - Shoulder Innovations Inset Reverse Total Shoulder - Shoulder Innovations, Inc.

Duns Number:080404519

Device Description: Shoulder Innovations Inset Reverse Total Shoulder - RSA Offset Bearing Trial 33 x 3mm

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More Product Details

Catalog Number

2R2HB33003

Brand Name

Shoulder Innovations Inset Reverse Total Shoulder

Version/Model Number

RSA Offset Bearing Trial 33 x 3mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

MBF

Product Code Name

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

Device Record Status

Public Device Record Key

452eae90-856f-4fd1-be06-f6142c868ccb

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHOULDER INNOVATIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 443