BioWick SureLock® - CAYENNE MEDICAL, INC.

Duns Number:606719685

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More Product Details

Catalog Number

CM-6101

Brand Name

BioWick SureLock®

Version/Model Number

CM-6101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

HTW

Product Code Name

Bit, Drill

Device Record Status

Public Device Record Key

f6aae92d-5dc7-4dbb-bbac-40559a93921a

Public Version Date

April 08, 2019

Public Version Number

1

DI Record Publish Date

March 29, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAYENNE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 166
2 A medical device with a moderate to high risk that requires special controls. 147