Abbott Medical - Probe Covers Clear Polyethylene Sterile 9in x - TIDI PRODUCTS, LLC

Duns Number:063519193

Device Description: Probe Covers Clear Polyethylene Sterile 9in x 96in x 1 in, 100 per Case

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More Product Details

Catalog Number

-

Brand Name

Abbott Medical

Version/Model Number

33442

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)

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

IYO

Product Code Name

System, Imaging, Pulsed Echo, Ultrasonic

Device Record Status

Public Device Record Key

2e2dc1a8-a18c-4342-975c-f227ee4d9dbc

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Additional Identifiers

Package DI Number

10618125188632

Quantity per Package

100

Contains DI Package

00618125188635

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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