4.0 X 125MM TAP - 4.0 X 125MM TAP - SMV SCIENTIFIC LLC

Duns Number:089645059

Device Description: 4.0 X 125MM TAP

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More Product Details

Catalog Number

303-4012

Brand Name

4.0 X 125MM TAP

Version/Model Number

303-4012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

HWX

Product Code Name

Tap, Bone

Device Record Status

Public Device Record Key

0b4bd21b-e91b-4252-a2e5-81a3437ce1e9

Public Version Date

February 24, 2022

Public Version Number

1

DI Record Publish Date

February 16, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMV SCIENTIFIC LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 60
2 A medical device with a moderate to high risk that requires special controls. 846