SEA-LINK Anterior Cervical Ø 4.5 mm L 10 mm Variable Angle Self Drilling Screw - SEA-LINK Anterior Cervical Plate System Ø 4.5 mm - INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Duns Number:860396609

Device Description: SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 10 mm Variable Angle Self Drilling Scre SEA-LINK Anterior Cervical Plate System Ø 4.5 mm L 10 mm Variable Angle Self Drilling Screw

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More Product Details

Catalog Number

A003.4510

Brand Name

SEA-LINK Anterior Cervical Ø 4.5 mm L 10 mm Variable Angle Self Drilling Screw

Version/Model Number

A003.4510

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code Details

Product Code

KWQ

Product Code Name

Appliance, Fixation, Spinal Intervertebral Body

Device Record Status

Public Device Record Key

1cc65235-e7fe-4852-8d43-082540525165

Public Version Date

January 28, 2021

Public Version Number

1

DI Record Publish Date

January 20, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 55
2 A medical device with a moderate to high risk that requires special controls. 124