PERFECTO - PERFECTO HEAVY BODY SHM TUBE KIT - CROWN DELTA CORPORATION

Duns Number:030479000

Device Description: PERFECTO HEAVY BODY SHM TUBE KIT

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More Product Details

Catalog Number

DW58

Brand Name

PERFECTO

Version/Model Number

DW58

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

-

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

ELW

Product Code Name

Material, Impression

Device Record Status

Public Device Record Key

f193d245-4ded-4c89-8e1c-85886842752a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CROWN DELTA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 46