Pantera Pro - Biotronik AG

Duns Number:480862817

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More Product Details

Catalog Number

393292

Brand Name

Pantera Pro

Version/Model Number

1.50/10/140

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

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

K160985

Product Code Details

Product Code

LOX

Product Code Name

Catheters, transluminal coronary angioplasty, percutaneous

Device Record Status

Public Device Record Key

b7a010f0-f6c0-4285-be9b-f30b0fccf8e5

Public Version Date

October 07, 2019

Public Version Number

4

DI Record Publish Date

October 17, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOTRONIK AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 441
3 A medical device with high risk that requires premarket approval 337