Cordera Hip System Femoral Reusable Instrument Tray, insert and base - Femoral Reusable Instrument Tray, insert and base - Conformis, Inc.

Duns Number:808821883

Device Description: Femoral Reusable Instrument Tray, insert and base

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More Product Details

Catalog Number

1080-122

Brand Name

Cordera Hip System Femoral Reusable Instrument Tray, insert and base

Version/Model Number

1080-122

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

-

Product Code Details

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

5067c89f-399d-4bfa-b191-dd26b5ebe09a

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

March 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CONFORMIS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 109
2 A medical device with a moderate to high risk that requires special controls. 1451