REDI-CUT® - REDI-CUT® #11 Non-Sterile Retractable Sheath - MYCO MEDICAL SUPPLIES INC.

Duns Number:879187821

Device Description: REDI-CUT® #11 Non-Sterile Retractable Sheath Scalpel with Technocut Premium Blade

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More Product Details

Catalog Number

RCRSS11NS

Brand Name

REDI-CUT®

Version/Model Number

RCRSS11NS

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

GES

Product Code Name

Blade, Scalpel

Device Record Status

Public Device Record Key

f58bc481-2948-41b8-a2cb-4f790fc4a52c

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MYCO MEDICAL SUPPLIES INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 471