Catalog Number

1001-1112

Brand Name

Scanlan® SURG-I-BAND® Color Coding - Data Matrix

Version/Model Number

1001-1112

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FWZ

Product Code Name

Operating Room Accessories Table Tray

Public Device Record Key

d91d6213-1eec-47c5-a5e0-c45e5669273e

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-