C.I.™ - Fine #1 C.I.™ Stainless Steel Post Refill (Pkg. - PARKELL, INC.

Duns Number:009900424

Device Description: Fine #1 C.I.™ Stainless Steel Post Refill (Pkg. of 10 pcs.)

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More Product Details

Catalog Number

S105

Brand Name

C.I.™

Version/Model Number

S105

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)

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

ELR

Product Code Name

Post, Root Canal

Device Record Status

Public Device Record Key

7c5649c0-ab19-4ccc-994c-3f0cbd6f4287

Public Version Date

April 15, 2019

Public Version Number

1

DI Record Publish Date

April 05, 2019

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