Sklar® - IRIS SCISS CRV STRL 4 1/2 100 - SKLAR CORPORATION

Duns Number:006966006

Device Description: IRIS SCISS CRV STRL 4 1/2 100

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Sklar®

Version/Model Number

96-2651M

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"

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 Details

Product Code

LRW

Product Code Name

SCISSORS, GENERAL, SURGICAL

Device Record Status

Public Device Record Key

f53e57c1-9b57-479c-b7e8-57d9d8b982b1

Public Version Date

September 23, 2022

Public Version Number

4

DI Record Publish Date

October 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SKLAR CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 13420
2 A medical device with a moderate to high risk that requires special controls. 881