USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter - USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter - BUTTERFLY NETWORK, INC.

Duns Number:064617010

Device Description: USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter

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More Product Details

Catalog Number

-

Brand Name

USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter

Version/Model Number

490-00187-01

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"

Yes

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

K163510

Product Code Details

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Device Record Status

Public Device Record Key

3c73a640-03b9-4d22-bc0f-bce776437968

Public Version Date

October 07, 2020

Public Version Number

1

DI Record Publish Date

September 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BUTTERFLY NETWORK, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13