Aggeris™-C - AGGERIS-C FIXED SCREW Diameter 4.5x12MM - CLARIANCE

Duns Number:296568400

Device Description: AGGERIS-C FIXED SCREW Diameter 4.5x12MM SELF-TAPPING

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More Product Details

Catalog Number

43064512

Brand Name

Aggeris™-C

Version/Model Number

43064512

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

K220182

Product Code Details

Product Code

KWQ

Product Code Name

Appliance, fixation, spinal intervertebral body

Device Record Status

Public Device Record Key

2971c38c-61c8-483c-ba6a-5da7fd16cb40

Public Version Date

May 16, 2022

Public Version Number

1

DI Record Publish Date

May 08, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CLARIANCE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 2450