Catalog Number

SKD-5

Brand Name

AllCare

Version/Model Number

SKD-5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

GDI

Product Code Name

Dissector, Surgical, General & Plastic Surgery

Public Device Record Key

2c3bfb23-ca24-48b7-a0b0-cce2450e4efe

Public Version Date

October 01, 2020

Public Version Number

1

DI Record Publish Date

September 23, 2020

Package DI Number

30182921000756

Quantity per Package

100

Contains DI Package

00182921000755

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-