DOUBLE HAND HELD CHEEK RETRACTORS - MAXILL, INC.

Duns Number:079343581

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More Product Details

Catalog Number

-

Brand Name

DOUBLE HAND HELD CHEEK RETRACTORS

Version/Model Number

6070541510

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)

-

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

0493c691-111e-4917-bcde-c60e5f004d7d

Public Version Date

August 01, 2022

Public Version Number

1

DI Record Publish Date

July 22, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAXILL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 208
2 A medical device with a moderate to high risk that requires special controls. 61