LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter - LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter - BUTTERFLY NETWORK, INC.

Duns Number:064617010

Device Description: LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter

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More Product Details

Catalog Number

-

Brand Name

LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter

Version/Model Number

490-00189-03

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

ec72a712-e8a1-41ad-82c0-6ff4209d0cd6

Public Version Date

March 18, 2021

Public Version Number

1

DI Record Publish Date

March 10, 2021

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