CitreLock 2.4mm K-Wire, Trocar Tip - Acuitive Technologies, Inc.

Duns Number:074645634

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More Product Details

Catalog Number

40-101-0004

Brand Name

CitreLock 2.4mm K-Wire, Trocar Tip

Version/Model Number

40-101-0004

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

K200725

Product Code Details

Product Code

HWQ

Product Code Name

Passer

Device Record Status

Public Device Record Key

bc61a900-60d7-4ce4-91bb-cfd6935a783a

Public Version Date

December 02, 2020

Public Version Number

1

DI Record Publish Date

November 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACUITIVE TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 22