9015 REUSABLE NOSECLIPS - NOSE CLIP ASSY REUSEABLE 9015 - HANS RUDOLPH, INC.

Duns Number:007131725

Device Description: NOSE CLIP ASSY REUSEABLE 9015

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More Product Details

Catalog Number

112571

Brand Name

9015 REUSABLE NOSECLIPS

Version/Model Number

9015

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"

-

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

BXJ

Product Code Name

Clip, Nose

Device Record Status

Public Device Record Key

00b57186-821e-4bac-b6fa-67b768ab75ea

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 08, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HANS RUDOLPH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 922
2 A medical device with a moderate to high risk that requires special controls. 407