NA - LOW PROF LCKNG SCREW F/IM NAIL Ø 5.0MM / L 88MM / - SYNTHES (U.S.A.) LP

Duns Number:832637081

Device Description: LOW PROF LCKNG SCREW F/IM NAIL Ø 5.0MM / L 88MM / XL25/ STER

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

04045388TS

Brand Name

NA

Version/Model Number

04.045.388TS

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

K201336,K201346

Product Code Details

Product Code

HSB

Product Code Name

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Record Status

Public Device Record Key

7f6d831f-379d-48a5-b287-e1a5611575d1

Public Version Date

June 03, 2021

Public Version Number

1

DI Record Publish Date

May 26, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNTHES (U.S.A.) LP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1194
2 A medical device with a moderate to high risk that requires special controls. 4171
3 A medical device with high risk that requires premarket approval 30
U Unclassified 1