Parkell® - Parkell® Universal Adhesive Kit - PARKELL, INC.

Duns Number:009900424

Device Description: Parkell® Universal Adhesive Kit

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More Product Details

Catalog Number

S264

Brand Name

Parkell®

Version/Model Number

S264

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 16, 2020

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

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Device Record Status

Public Device Record Key

88826b04-fed4-4e23-a2e3-313a4dd8d8c1

Public Version Date

November 24, 2020

Public Version Number

2

DI Record Publish Date

October 19, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARKELL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 476
U Unclassified 19