Safco panoramic film - Safco DX-75 panoramic 5x12 blue 50 per bx - SAFCO DENTAL SUPPLY CO.

Duns Number:020417380

Device Description: Safco DX-75 panoramic 5x12 blue 50 per bx

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More Product Details

Catalog Number

2740010

Brand Name

Safco panoramic film

Version/Model Number

2740010

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)

-

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

IWZ

Product Code Name

Film, radiographic

Device Record Status

Public Device Record Key

76fd3122-9b68-4212-8a70-4e594e301b4b

Public Version Date

September 16, 2020

Public Version Number

1

DI Record Publish Date

September 08, 2020

Additional Identifiers

Package DI Number

D72327400103

Quantity per Package

3

Contains DI Package

D7232740010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SAFCO DENTAL SUPPLY CO." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 600
2 A medical device with a moderate to high risk that requires special controls. 23