Tricut - BLADE 1882904HRE M4 TRICUT 2.9MM ROTAT - MEDTRONIC XOMED, INC.

Duns Number:835465063

Device Description: BLADE 1882904HRE M4 TRICUT 2.9MM ROTAT

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More Product Details

Catalog Number

-

Brand Name

Tricut

Version/Model Number

1882904HRE

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

989ca7b6-15fa-46c2-b9d6-55bb62a3edd9

Public Version Date

October 15, 2021

Public Version Number

1

DI Record Publish Date

October 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC XOMED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 665
2 A medical device with a moderate to high risk that requires special controls. 1575
3 A medical device with high risk that requires premarket approval 6
U Unclassified 10