MediChoice - Speculum Vaginal With Built-In Led Light Source - OWENS & MINOR DISTRIBUTION, INC.

Duns Number:007941230

Device Description: Speculum Vaginal With Built-In Led Light Source Small Premium Adjustable Locking Disposabl Speculum Vaginal With Built-In Led Light Source Small Premium Adjustable Locking Disposable Clear Not Made With Natural Rubber Latex MediChoice

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

MediChoice

Version/Model Number

VAG3001

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

HIB

Product Code Name

Speculum, vaginal, nonmetal

Device Record Status

Public Device Record Key

d078dc51-2bca-44af-bd58-155613329d7e

Public Version Date

October 16, 2020

Public Version Number

1

DI Record Publish Date

October 08, 2020

Additional Identifiers

Package DI Number

30885632129340

Quantity per Package

25

Contains DI Package

10885632129346

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