20G X 5/8" PRO-LOCK CT SAFETY INFUSION SET20G X 5/8" PRO-LOCK CT SAFETY INFUSION - 20G X 5/8" (15MM) PRO-LOCK20G X CT SAFETY - Medical Components, Inc.

Duns Number:038000253

Device Description: 20G X 5/8" (15MM) PRO-LOCK20G X CT SAFETY INFUSION SETCT SAFETY

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More Product Details

Catalog Number

MRH2063

Brand Name

20G X 5/8" PRO-LOCK CT SAFETY INFUSION SET20G X 5/8" PRO-LOCK CT SAFETY INFUSION

Version/Model Number

MRH2063

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

PTI

Product Code Name

Non-Coring (Huber) Needle

Device Record Status

Public Device Record Key

65edf93b-74de-477e-bd1d-cd248ddba4f5

Public Version Date

October 23, 2019

Public Version Number

3

DI Record Publish Date

February 06, 2019

Additional Identifiers

Package DI Number

50884908127787

Quantity per Package

8

Contains DI Package

30884908127783

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