Sterilization Case, Implant Selection Device - Reusable, stainless steel instrument storage case - Curvafix Inc

Duns Number:039779098

Device Description: Reusable, stainless steel instrument storage case that is used to contain the implant sele Reusable, stainless steel instrument storage case that is used to contain the implant selection device during sterilization processing in preparation for pelvic fixation procedure.

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More Product Details

Catalog Number

CIC-002

Brand Name

Sterilization Case, Implant Selection Device

Version/Model Number

CIC-002

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

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Device Record Status

Public Device Record Key

82228a1d-69eb-4085-a263-6107a6ec6cbf

Public Version Date

December 10, 2021

Public Version Number

1

DI Record Publish Date

December 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CURVAFIX INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 51