MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR - 12F VESSEL DILATOR12F VESSEL DIL (15CM / - Medical Components, Inc.

Duns Number:038000253

Device Description: 12F VESSEL DILATOR12F VESSEL DIL (15CM / 0.038")(15CM / 0.038")

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More Product Details

Catalog Number

MCD72

Brand Name

MEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR

Version/Model Number

MCD72

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

DRE

Product Code Name

DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Device Record Status

Public Device Record Key

680c3e8e-4376-414d-843e-d69dc1c5a5da

Public Version Date

November 06, 2018

Public Version Number

1

DI Record Publish Date

October 06, 2018

Additional Identifiers

Package DI Number

50884908127343

Quantity per Package

10

Contains DI Package

00884908127348

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