Surgilast® - Surgilast Tubular Elastic Dressing Retainer Size - Derma Sciences Canada Inc

Duns Number:200564891

Device Description: Surgilast Tubular Elastic Dressing Retainer Size 6 - 25 Yards Stretched

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More Product Details

Catalog Number

GL-707

Brand Name

Surgilast®

Version/Model Number

707

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FQM

Product Code Name

BANDAGE, ELASTIC

Device Record Status

Public Device Record Key

fe498135-16e1-401d-b2b3-2bd5b093d892

Public Version Date

August 19, 2019

Public Version Number

2

DI Record Publish Date

October 23, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DERMA SCIENCES CANADA INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 254
2 A medical device with a moderate to high risk that requires special controls. 15
U Unclassified 42