Catalog Number

SDPS-C003

Brand Name

ULTRAGATOR

Version/Model Number

SDPS-C003

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"

-

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

GFA

Product Code Name

BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Public Device Record Key

61811fb9-351d-4dff-b710-512333eabf4e

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

October 20, 2017

Package DI Number

20845854605711

Quantity per Package

6

Contains DI Package

10845854605714

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON