Catalog Number

1001-1084

Brand Name

Scanlan® SURG-I-BAND® color coding

Version/Model Number

1001-1084

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

40b90559-9bb5-4b9c-bdca-fa117b61111d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-