Apogee IC - Intermittent catheter, 14 Fr 16 in, Straight - HOLLISTER INCORPORATED

Duns Number:005527098

Device Description: Intermittent catheter, 14 Fr 16 in, Straight

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More Product Details

Catalog Number

-

Brand Name

Apogee IC

Version/Model Number

11416

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

GBM

Product Code Name

CATHETER, URETHRAL

Device Record Status

Public Device Record Key

7fd850e0-2284-4465-b2eb-ce6d8692a741

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

20610075205244

Quantity per Package

12

Contains DI Package

00610075205240

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"HOLLISTER INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 30