Causse - PROSTHESIS 1129055 CAUSSE LP .8X.6DX6L - MEDTRONIC XOMED, INC.

Duns Number:835465063

Device Description: PROSTHESIS 1129055 CAUSSE LP .8X.6DX6L

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More Product Details

Catalog Number

-

Brand Name

Causse

Version/Model Number

1129055

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

-

Product Code Details

Product Code

ETA

Product Code Name

REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Device Record Status

Public Device Record Key

574a9df3-4886-4220-bba1-9872d4d132c9

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC XOMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 665
2 A medical device with a moderate to high risk that requires special controls. 1575
3 A medical device with high risk that requires premarket approval 6
U Unclassified 10