DIEGO POWERED DISSECTOR ADENOID BLADE, AGGRESSIVE 4MM DIAMETER CONVEX - Gyrus Acmi, Inc.

Duns Number:007198742

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More Product Details

Catalog Number

-

Brand Name

DIEGO POWERED DISSECTOR ADENOID BLADE, AGGRESSIVE 4MM DIAMETER CONVEX

Version/Model Number

70138106

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

EQJ

Product Code Name

BUR, EAR, NOSE AND THROAT

Device Record Status

Public Device Record Key

7a76285f-19b9-4a68-9e2a-66c90a07d799

Public Version Date

October 15, 2018

Public Version Number

1

DI Record Publish Date

September 12, 2018

Additional Identifiers

Package DI Number

00821925027220

Quantity per Package

6

Contains DI Package

00821925040458

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