Catalog Number

3855

Brand Name

Grafco

Version/Model Number

3855

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

cc5fa160-7665-42f5-b7f2-71215aeb8693

Public Version Date

October 22, 2020

Public Version Number

1

DI Record Publish Date

October 14, 2020

Package DI Number

M36838552

Quantity per Package

200

Contains DI Package

M36838551

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-