Sheathes - Latex, 1"D x 8"L, Sterile, Ultrasound Probe Cover - SHEATHING TECHNOLOGIES, INC.

Duns Number:806806220

Device Description: Latex, 1"D x 8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless Latex, 1"D x 8"L, Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Improved Narrow, Rolled

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More Product Details

Catalog Number

-

Brand Name

Sheathes

Version/Model Number

10740

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)

Yes

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

K925869,K925869,K925869

Product Code Details

Product Code

ITX

Product Code Name

Transducer, Ultrasonic, Diagnostic

Device Record Status

Public Device Record Key

c5bcaf85-e557-4b5f-b50e-2c6bd6a0dd06

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

20842418100200

Quantity per Package

6

Contains DI Package

10842418100203

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