Spetzler T2 Clip Applier Rack - Spetzler T2 Clip Applier Rack - MIZUHO CORPORATION

Duns Number:690677802

Device Description: Spetzler T2 Clip Applier Rack

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More Product Details

Catalog Number

17-016-00

Brand Name

Spetzler T2 Clip Applier Rack

Version/Model Number

17-016-00

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

-

Product Code Details

Product Code

HAO

Product Code Name

Instrument, Surgical, Non-Powered

Device Record Status

Public Device Record Key

2e85debd-ad81-464d-b787-d08003c9c4ab

Public Version Date

April 20, 2022

Public Version Number

1

DI Record Publish Date

April 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIZUHO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 696
2 A medical device with a moderate to high risk that requires special controls. 566