Catalog Number

-

Brand Name

SAM Pelvic Sling II

Version/Model Number

PS301-OB-EN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IPW

Product Code Name

Orthosis, Sacroiliac, Soft

Public Device Record Key

3ea76039-0347-4f87-8979-1f6edd071b9e

Public Version Date

September 09, 2022

Public Version Number

1

DI Record Publish Date

September 01, 2022

Package DI Number

10822045428635

Quantity per Package

24

Contains DI Package

00822045428638

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case