QMS - 48CFST - QUALITY MEDICAL SUPPLY, INC.

Duns Number:969138283

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More Product Details

Catalog Number

150

Brand Name

QMS - 48CFST

Version/Model Number

01

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

FFQ

Product Code Name

Speculum, Rectal

Device Record Status

Public Device Record Key

7b0ce0dc-a424-456b-a868-b5fb2d99a5a3

Public Version Date

December 20, 2019

Public Version Number

1

DI Record Publish Date

December 12, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"QUALITY MEDICAL SUPPLY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 1