DISPOSABLE MYRINGOTOMY BLADE STRAIGHT EDGE STRAIGHT TAPERED SHAFT STA - Gyrus Acmi, Inc.

Duns Number:007198742

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More Product Details

Catalog Number

-

Brand Name

DISPOSABLE MYRINGOTOMY BLADE STRAIGHT EDGE STRAIGHT TAPERED SHAFT STA

Version/Model Number

70130929

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

LRC

Product Code Name

INSTRUMENT, ENT MANUAL SURGICAL

Device Record Status

Public Device Record Key

d914386d-bbb3-44f7-9b50-3b993dd78df9

Public Version Date

June 08, 2021

Public Version Number

3

DI Record Publish Date

September 11, 2018

Additional Identifiers

Package DI Number

00821925024915

Quantity per Package

6

Contains DI Package

00821925034815

Package Discontinue Date

-

Package Status

In Commercial Distribution

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