RICHARDS SINUSCOPE ADAPTOR FOR LIGHT CABLE - Gyrus Acmi, Inc.

Duns Number:007198742

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More Product Details

Catalog Number

-

Brand Name

RICHARDS SINUSCOPE ADAPTOR FOR LIGHT CABLE

Version/Model Number

230557

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

-

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

K932988

Product Code Details

Product Code

EOB

Product Code Name

NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Device Record Status

Public Device Record Key

f2d5ecf0-9817-4522-b2bb-3b8095dffff9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 09, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GYRUS ACMI, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 899
2 A medical device with a moderate to high risk that requires special controls. 1586
3 A medical device with high risk that requires premarket approval 9
U Unclassified 4