Sheathes3D - Seamless Viral Barrier Box End, Polyurethane, 1" - SHEATHING TECHNOLOGIES, INC.

Duns Number:806806220

Device Description: Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 24"L, Extended Field Seamless Viral Barrier Box End, Polyurethane, 1" x 3.2" Face to 6"W x 24"L, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled

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More Product Details

Catalog Number

-

Brand Name

Sheathes3D

Version/Model Number

50001-IL246NS

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K153212,K153212,K153212

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

5d0c976d-b4c6-44bb-94cc-802c16053586

Public Version Date

January 20, 2021

Public Version Number

1

DI Record Publish Date

January 12, 2021

Additional Identifiers

Package DI Number

20842418104475

Quantity per Package

3

Contains DI Package

10842418104478

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"SHEATHING TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1