Biopor®
Catalog Number: | USL-4052 |
---|---|
Company Name: | CEREMED, INC. |
Device Combination Product: | N/A |
Device Commercial Dsitribution End Date: | N/A |
Device Commercial Dsitribution Status: | In Commercial Distribution |
Device Count: | 1 |
Device Description: | Medium Malar Shell L |
Device hctp: | N/A |
Device kit: | N/A |
Device Publish Date: | 2016-07-20 |
Device Record Status: | Published |
Direct Market Exempt: | N/A |
Has Donation ID number? | N/A |
DUNS Number: | 626959824 |
Has Expiration Date? | true |
Is Labelled as NRL: | N/A |
Is Labelled As No NRL: | N/A |
Has Lot Batch Number: | true |
Has Manufacutring Date: | N/A |
MRI Safety Status: | Labeling does not contain MRI Safety Information |
Is OTC? | N/A |
Is Devic Premarket Exempt: | N/A |
Public Device Record Key: | 586c72ad-5978-47c8-9417-67ef3eab0448 |
Public Version Date: | 2018-03-29 |
Public Version Number: | 2 |
Public Version Status: | Update |
Is Rx? | true |
Has Serial Number? | N/A |
Is Single Use: | true |
Version Model Number: | USL-4052 |
Adress: | Phone:310-815-2125 Extension: Email: info@ceremed.com |
Storage Condition
Storage Handling Type
Storage Handling High
Storage Handling Low
Storage Handling Special Condition
N/A
N/A
N/A
N/A
GMDN Terms
GMDN Name
GMDN Term Definition
Polyethylene craniofacial tissue reconstructive material
A sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
USL40520
Primary
HIBCC
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
true
false
Product Codes
Product Code
Product Code Name
KKY
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Pre Market Submisison
Submission Number
Supplement Number
N/A
N/A