Sheathes - Latex-Free, 1"D x 11.8"L, Non-Sterile, Ultrasound - SHEATHING TECHNOLOGIES, INC.

Duns Number:806806220

Device Description: Latex-Free, 1"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rect Latex-Free, 1"D x 11.8"L, Non-Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Tapered, Rolled, Extra-Long

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More Product Details

Catalog Number

-

Brand Name

Sheathes

Version/Model Number

25386

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

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

5526dbef-f68a-401f-acef-780582aaf269

Public Version Date

May 23, 2018

Public Version Number

2

DI Record Publish Date

March 07, 2018

Additional Identifiers

Package DI Number

10842418102269

Quantity per Package

6

Contains DI Package

10842418102269

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