Medichoice - Speculum Vaginal Medium Disposable Clear Not Made - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Speculum Vaginal Medium Disposable Clear Not Made With Natural Rubber Latex MediChoice

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More Product Details

Catalog Number

-

Brand Name

Medichoice

Version/Model Number

VAG1002

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"

Yes

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

-

Product Code Details

Product Code

JOL

Product Code Name

CATHETER AND TIP, SUCTION

Device Record Status

Public Device Record Key

202b2c41-551e-4c6c-85df-ba97330bd057

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 20, 2016

Additional Identifiers

Package DI Number

30885632101407

Quantity per Package

10

Contains DI Package

10885632101403

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OWENS & MINOR DISTRIBUTION, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 428
2 A medical device with a moderate to high risk that requires special controls. 8754
U Unclassified 1