SCANLAN® Easy-Tag™ Tracking System - Easy-Tag, Mini, Pink, 250/BX - SCANLAN INTERNATIONAL INC

Duns Number:023055619

Device Description: Easy-Tag, Mini, Pink, 250/BX

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More Product Details

Catalog Number

1001-969

Brand Name

SCANLAN® Easy-Tag™ Tracking System

Version/Model Number

1001-969

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

FWZ

Product Code Name

Operating Room Accessories Table Tray

Device Record Status

Public Device Record Key

6b99d3e4-b28d-4528-bf16-2a87cd66dd81

Public Version Date

November 11, 2021

Public Version Number

1

DI Record Publish Date

November 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCANLAN INTERNATIONAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1949
2 A medical device with a moderate to high risk that requires special controls. 855