TAP - Device for treatment of mild to moderate - James R. Glidewell, Dental Ceramics, Inc.

Duns Number:021228671

Device Description: Device for treatment of mild to moderate obstructive sleep apnea

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More Product Details

Catalog Number

TAP

Brand Name

TAP

Version/Model Number

TAP

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

-

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

LRK

Product Code Name

Device, anti-snoring

Device Record Status

Public Device Record Key

293ebb80-6018-495d-84e4-a0a65c34f346

Public Version Date

November 01, 2021

Public Version Number

2

DI Record Publish Date

September 23, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JAMES R. GLIDEWELL, DENTAL CERAMICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 510
2 A medical device with a moderate to high risk that requires special controls. 2971
U Unclassified 2