BBraun Multi-Snare - Multi-Snare Set 10mm x 125cm - PFM MEDICAL INCORPORATED

Duns Number:097736867

Device Description: Multi-Snare Set 10mm x 125cm

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More Product Details

Catalog Number

612973

Brand Name

BBraun Multi-Snare

Version/Model Number

612973

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

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

K011783,K011783,K011783,K011783

Product Code Details

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Device Record Status

Public Device Record Key

ce3f2a61-4077-4448-a5a1-e5f819026677

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

September 29, 2016

Additional Identifiers

Package DI Number

30813623011299

Quantity per Package

1

Contains DI Package

00813623011298

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PFM MEDICAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 109