ORTHO SOLUTIONS STERILE DRILL BITS - 6.5/8.0MM COUNTERSINK - ORTHO SOLUTIONS HOLDINGS LIMITED

Duns Number:218648211

Device Description: 6.5/8.0MM COUNTERSINK

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More Product Details

Catalog Number

OS309008

Brand Name

ORTHO SOLUTIONS STERILE DRILL BITS

Version/Model Number

OS309008

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K102743

Product Code Details

Product Code

HWE

Product Code Name

Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Device Record Status

Public Device Record Key

c177c972-4a4e-48c5-afe6-8d7d0e43e9a8

Public Version Date

August 05, 2019

Public Version Number

1

DI Record Publish Date

July 26, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO SOLUTIONS HOLDINGS LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 262
2 A medical device with a moderate to high risk that requires special controls. 1530