Biopor® CSP-0019

GUDID CSP00190

Orbiral Spheres - AOC Coated - ø19mm

CEREMED, INC.

Polyethylene craniofacial tissue reconstructive material
Primary Device IDCSP00190
NIH Device Record Keya841e6d2-e66f-4b5c-8b04-c523ec352058
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiopor®
Version Model NumberCSP-0019
Catalog NumberCSP-0019
Company DUNS626959824
Company NameCEREMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone310-815-2125
Emailinfo@ceremed.com
Phone310-815-2125
Emailinfo@ceremed.com

Device Dimensions

Outer Diameter19 Millimeter
Outer Diameter19 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCCSP00190 [Primary]

FDA Product Code

KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-07-20

On-Brand Devices [Biopor®]

CSR50520Large Malar Shell R
CSR40520Medium Malar Shell R
CSR30520Small Malar Shell R
CSP00220Orbiral Spheres - AOC Coated - ø22mm
CSP00210Orbiral Spheres - AOC Coated - ø21mm
CSP00200Orbiral Spheres - AOC Coated - ø20mm
CSP00190Orbiral Spheres - AOC Coated - ø19mm
CSP00180Orbiral Spheres - AOC Coated - ø18mm
CSP00160Orbiral Spheres - AOC Coated - ø16mm
CSL50520Large Malar Shell L
CSL40520Medium Malar Shell L
CSL30520Small Malar Shell L
CSH30580Sheet 3 x 50 x 80 mm
CSH30540Sheet 3 x 50 x 40 mm
CSH15580Sheet 1.5 x 50 x 80 mm
CSH15540Sheet 1.5 x 50 x 40 mm
CSH08580Sheet 0.80 x 50 x 80 mm
CSH08540Sheet 0.80 x 50 x 40 mm
CSH05580Sheet 0.45 x 50 x 80 mm
CSH05540Sheet 0.45 x 50 x 40 mm
CMR60520Large Malar Right
CMR45520Medium Malar Right
CMR30520Small Malar Right
CML60520Large Malar Left
CML45520Medium Malar Left
CML30520Small Malar Left
CCS90640Large Square Chin
CCS60640Medium Square Chin
CCS40640Small Square Chin
CCR90640Large Round Chin
CCR60640Medium Round Chin
CCR40640Small Round Chin

Trademark Results [Biopor]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOPOR
BIOPOR
79212228 5367052 Live/Registered
Dreve Otoplastik GmbH
2017-05-18
BIOPOR
BIOPOR
75842712 2484486 Live/Registered
CEREMED, INC.
1999-11-08
BIOPOR
BIOPOR
74322147 not registered Dead/Abandoned
BIOTEC Biologische Naturverpackungen GmbH & Co. Produktions- und Marketing KG
1992-10-14
BIOPOR
BIOPOR
73052239 1029987 Dead/Expired
POREX MATERIALS CORPORATION
1975-05-13

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