Sopro - Intraoral Camera Covers Clear Polyethylene - TIDI PRODUCTS, LLC

Duns Number:063519193

Device Description: Intraoral Camera Covers Clear Polyethylene

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More Product Details

Catalog Number

403017

Brand Name

Sopro

Version/Model Number

20941

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

b1dad8ba-dc48-4bb5-94b4-9ea8f3829d7f

Public Version Date

October 20, 2022

Public Version Number

1

DI Record Publish Date

October 12, 2022

Additional Identifiers

Package DI Number

10618125121080

Quantity per Package

5000

Contains DI Package

00618125121083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TIDI PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 2255