R-55 Circlet Packing Instrument Serrated - Retraction Cord Packing Instrument Circlet with - PASCAL COMPANY, INC.

Duns Number:009260217

Device Description: Retraction Cord Packing Instrument Circlet with Serrated tip

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More Product Details

Catalog Number

26130

Brand Name

R-55 Circlet Packing Instrument Serrated

Version/Model Number

26130

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)

-

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

EIF

Product Code Name

Accessories, Retractor, Dental

Device Record Status

Public Device Record Key

33c79bd7-9255-4fde-a256-ab78f10262c2

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 31, 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