5P NAVY HI PULL W/SLIP ON *O - 5P NAVY HI PULL W/SLIP ON *O - Great Lakes Dental Technologies, Ltd.

Duns Number:041854332

Device Description: 5P NAVY HI PULL W/SLIP ON *O

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More Product Details

Catalog Number

300-106

Brand Name

5P NAVY HI PULL W/SLIP ON *O

Version/Model Number

300-106

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

DZB

Product Code Name

Headgear, Extraoral, Orthodontic

Device Record Status

Public Device Record Key

383a3b67-ea22-4dae-9949-4f3f89cfda04

Public Version Date

February 02, 2021

Public Version Number

3

DI Record Publish Date

May 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GREAT LAKES DENTAL TECHNOLOGIES, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 45
2 A medical device with a moderate to high risk that requires special controls. 183