Pascord Retraction Cord 10/2 - Twisted Gingival Retraction Cord with Aluminum - PASCAL COMPANY, INC.

Duns Number:009260217

Device Description: Twisted Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 10/2

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More Product Details

Catalog Number

07620

Brand Name

Pascord Retraction Cord 10/2

Version/Model Number

07620

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

58830385-8820-4ca9-9ebe-991b00163dc9

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