NA - CONTINUOUS NERVE BLOCK TRAY E-Cath with - PAJUNK MEDICAL SYSTEMS, LP

Duns Number:136718553

Device Description: CONTINUOUS NERVE BLOCK TRAY E-Cath with Indwelling Catheter 18G x 83mm (3-1/4")

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

TDLC204

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

-

Product Code Details

Product Code

OGJ

Product Code Name

Nerve Block Tray

Device Record Status

Public Device Record Key

dc51b222-04db-44c9-a7e3-abdc6b88d75d

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 2020

Additional Identifiers

Package DI Number

20858965006568

Quantity per Package

10

Contains DI Package

00858965006564

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PAJUNK MEDICAL SYSTEMS, LP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 41