Catalog Number

SIL1450X

Brand Name

MEDLINE

Version/Model Number

SIL1450X

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

92780d81-aab0-4545-8171-bdba16aa1159

Public Version Date

May 21, 2020

Public Version Number

1

DI Record Publish Date

May 13, 2020

Package DI Number

20193489015864

Quantity per Package

12

Contains DI Package

10193489015867

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE