Osteoplug - Dimensions: 8 x 8 x 4 mmMaterial: PCLIntended - OSTEOPORE INTERNATIONAL PTE. LTD.

Duns Number:894834738

Device Description: Dimensions: 8 x 8 x 4 mmMaterial: PCLIntended Use: The Osteopore PCL Scaffold Bone Filler Dimensions: 8 x 8 x 4 mmMaterial: PCLIntended Use: The Osteopore PCL Scaffold Bone Filler is intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.

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More Product Details

Catalog Number

-

Brand Name

Osteoplug

Version/Model Number

PC22(8,8,4)

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

K051093

Product Code Details

Product Code

GXP

Product Code Name

Methyl Methacrylate For Cranioplasty

Device Record Status

Public Device Record Key

f63d85e8-8986-4c8c-ae1c-3a35dc3c2132

Public Version Date

October 04, 2022

Public Version Number

1

DI Record Publish Date

September 26, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OSTEOPORE INTERNATIONAL PTE. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 33