Hermes PEEK Straight Cage - Hermes TyPEEK Straight Cage 8mmx24mmx10mm, 0° - Tyber Medical LLC

Duns Number:010968002

Device Description: Hermes TyPEEK Straight Cage 8mmx24mmx10mm, 0°

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More Product Details

Catalog Number

HRM-P248010-S

Brand Name

Hermes PEEK Straight Cage

Version/Model Number

HRM-P248010-S

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)

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

346d7f87-892e-4238-88c8-cd405a2b2e61

Public Version Date

May 29, 2020

Public Version Number

1

DI Record Publish Date

May 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TYBER MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 440
2 A medical device with a moderate to high risk that requires special controls. 7793