NA - BUSHING, CALCAR PLANER, BROACH HOLE ADAPTOR - Exactech, Inc.

Duns Number:157565946

Device Description: BUSHING, CALCAR PLANER, BROACH HOLE ADAPTOR

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More Product Details

Catalog Number

01-003-04-0004

Brand Name

NA

Version/Model Number

01-003-04-0004

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

K140674,K182462,K162732

Product Code Details

Product Code

JDI

Product Code Name

Prosthesis, hip, semi-constrained, metal/polymer, cemented

Device Record Status

Public Device Record Key

327ef943-bef7-4804-b691-b9178fbd963d

Public Version Date

August 05, 2022

Public Version Number

1

DI Record Publish Date

July 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXACTECH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3717
2 A medical device with a moderate to high risk that requires special controls. 7206
3 A medical device with high risk that requires premarket approval 28