N/A - FILM PACK 50 PRINTS RIBBON 21/20MD 4PC - PENTAX OF AMERICA, INC.

Duns Number:083211284

Device Description: FILM PACK 50 PRINTS RIBBON 21/20MD 4PC

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More Product Details

Catalog Number

-

Brand Name

N/A

Version/Model Number

UPC-21L

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

KQM

Product Code Name

Camera, Surgical And Accessories

Device Record Status

Public Device Record Key

0ae7165e-be67-4d58-b942-9b0c1280ffd9

Public Version Date

April 16, 2018

Public Version Number

1

DI Record Publish Date

March 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PENTAX OF AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 247
2 A medical device with a moderate to high risk that requires special controls. 425