Catalog Number

AMS9537

Brand Name

Aligned Medical Solutions

Version/Model Number

AMS9537

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

-

FDA Premarket Submission

-

Product Code

OFT

Product Code Name

Spinal epidural anesthesia kit

Public Device Record Key

d9a398b6-5816-4f8e-aa8e-ff4e158d48d2

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

June 18, 2019

Package DI Number

B098AMS95371

Quantity per Package

20

Contains DI Package

B098AMS95370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case