icotec Lumbar Cage ETurn TLIF 10 x 12 mm - icotec Lumbar Cage ETurn TLIF 10 x 12 mm - icotec AG

Duns Number:480789465

Device Description: icotec Lumbar Cage ETurn TLIF 10 x 12 mm

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More Product Details

Catalog Number

13-57-12-32-10-ITi

Brand Name

icotec Lumbar Cage ETurn TLIF 10 x 12 mm

Version/Model Number

13-57-12-32-10-ITi

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"

-

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

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

0974b51b-1232-4840-89d5-2c036fc46915

Public Version Date

August 16, 2018

Public Version Number

1

DI Record Publish Date

July 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ICOTEC AG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 651