Disposable Safety Scalpel - #22 Sterile Safety Scalpel - Southmedic Incorporated

Duns Number:246848147

Device Description: #22 Sterile Safety Scalpel

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More Product Details

Catalog Number

73-0622

Brand Name

Disposable Safety Scalpel

Version/Model Number

73-0622

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)

Yes

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

4eb8b335-6f2a-45cc-8f91-6778de1fb39c

Public Version Date

October 12, 2020

Public Version Number

1

DI Record Publish Date

October 02, 2020

Additional Identifiers

Package DI Number

10620974002496

Quantity per Package

12

Contains DI Package

00620974002499

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SOUTHMEDIC INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 91
2 A medical device with a moderate to high risk that requires special controls. 18
3 A medical device with high risk that requires premarket approval 2