Racord Retraction Cord 9/1 - Twisted Gingival Retraction Cord with - PASCAL COMPANY, INC.

Duns Number:009260217

Device Description: Twisted Gingival Retraction Cord with Epinephrine, 72 inches, Size: 9/1

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More Product Details

Catalog Number

07710

Brand Name

Racord Retraction Cord 9/1

Version/Model Number

07710

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

MVL

Product Code Name

Cord, Retraction

Device Record Status

Public Device Record Key

b3b66462-3256-451d-a64e-e780e822de71

Public Version Date

March 01, 2019

Public Version Number

1

DI Record Publish Date

January 29, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PASCAL COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 34
2 A medical device with a moderate to high risk that requires special controls. 6
U Unclassified 57