DIGNITY® - 6.6F PLASTIC DIGNITY® MINI PROFILE CT PORT - Medical Components, Inc.

Duns Number:038000253

Device Description: 6.6F PLASTIC DIGNITY® MINI PROFILE CT PORT W/SILICONE FILLED SUTURE HOLES W/ATTACHABLE Chr 6.6F PLASTIC DIGNITY® MINI PROFILE CT PORT W/SILICONE FILLED SUTURE HOLES W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER

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More Product Details

Catalog Number

MRDP66AXS

Brand Name

DIGNITY®

Version/Model Number

MRDP66AXS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

LJT

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Device Record Status

Public Device Record Key

16c0eeeb-61c7-4663-addd-53782c001e43

Public Version Date

December 04, 2019

Public Version Number

1

DI Record Publish Date

November 26, 2019

Additional Identifiers

Package DI Number

50884908149871

Quantity per Package

5

Contains DI Package

00884908149876

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"MEDICAL COMPONENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 2560