IOPS™ - IOPS™ Catheter Reverse Curve 1 - CENTERLINE BIOMEDICAL, INC.

Duns Number:080088507

Device Description: IOPS™ Catheter Reverse Curve 1

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More Product Details

Catalog Number

RCC-1

Brand Name

IOPS™

Version/Model Number

RCC-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

-

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

K190106,K190106

Product Code Details

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Device Record Status

Public Device Record Key

619a5fec-18ae-49eb-8fb6-0a227fee17bf

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

September 18, 2020

Additional Identifiers

Package DI Number

10843152101037

Quantity per Package

5

Contains DI Package

00843152101030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"CENTERLINE BIOMEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7