Sheathes3D - 5-1245-IL4845, Bag, Polyurethane, 1" x 2.9" Face - SHEATHING TECHNOLOGIES, INC.

Duns Number:806806220

Device Description: 5-1245-IL4845, Bag, Polyurethane, 1" x 2.9" Face to 4.5"W x 48"L Ultrasound Probe Cover wi 5-1245-IL4845, Bag, Polyurethane, 1" x 2.9" Face to 4.5"W x 48"L Ultrasound Probe Cover with a 4.5"W x 12"L Ultrasound Probe Cover, Sterile, with 20ml Sterile Gel & 2 Elastics, Rolled

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More Product Details

Catalog Number

-

Brand Name

Sheathes3D

Version/Model Number

5-1245-IL4845

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

-

Product Code Details

Product Code

OIP

Product Code Name

Radiology-Diagnostic Kit

Device Record Status

Public Device Record Key

286cc960-87f4-4655-a0e3-c4a5ec3726da

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 13, 2021

Additional Identifiers

Package DI Number

20842418104642

Quantity per Package

3

Contains DI Package

10842418104645

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