envision Transducer Cover - Sterile (14 x 147cm) telescopically- folded - CIVCO MEDICAL INSTRUMENTS CO., INC.

Duns Number:134614411

Device Description: Sterile (14 x 147cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hyd Sterile (14 x 147cm) telescopically- folded CIV-Flex cover with PEELSafe Advantage and hydrophilic ultrasound pad

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More Product Details

Catalog Number

H2O-010, H2O-010-5

Brand Name

envision Transducer Cover

Version/Model Number

H2O-010, H2O-010-5

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K190802,K190802,K190802

Product Code Details

Product Code

ITX

Product Code Name

Transducer, ultrasonic, diagnostic

Device Record Status

Public Device Record Key

d3ae0249-623c-43be-897e-42c21eefe96f

Public Version Date

September 06, 2021

Public Version Number

2

DI Record Publish Date

June 19, 2019

Additional Identifiers

Package DI Number

00841436115025

Quantity per Package

5

Contains DI Package

10841436115015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CIVCO MEDICAL INSTRUMENTS CO., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 58
2 A medical device with a moderate to high risk that requires special controls. 443