Medline - DRILL GUIDE, POLYAXIAL CONE, 2.0/2.8MM - MEDLINE INDUSTRIES, INC.

Duns Number:025460908

Device Description: DRILL GUIDE, POLYAXIAL CONE, 2.0/2.8MM

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


More Product Details

Catalog Number

MPN40007

Brand Name

Medline

Version/Model Number

MPN40007

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

-

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

GAD

Product Code Name

RETRACTOR

Device Record Status

Public Device Record Key

8a6c5aba-c723-4a61-898c-761def804705

Public Version Date

September 07, 2020

Public Version Number

5

DI Record Publish Date

October 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDLINE INDUSTRIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38540
2 A medical device with a moderate to high risk that requires special controls. 85094
3 A medical device with high risk that requires premarket approval 2
U Unclassified 7