ProPlan CMF SD900.008

GUDID 05420060350573

Splint and Planning Kit, Orthognathic Kit, two Splints

Materialise NV

Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model
Primary Device ID05420060350573
NIH Device Record Key3169d06c-39f8-4e47-acdc-336590584c8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameProPlan CMF
Version Model NumberSD900.008
Catalog NumberSD900.008
Company DUNS373139427
Company NameMaterialise NV
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105420060350573 [Primary]

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


[05420060350573]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-04
Device Publish Date2021-04-26

On-Brand Devices [ProPlan CMF]

05420060355097Patient Specific Splint and Planning Kit, Orthognathic Kit, one Splint
05420060355080Patient Specific Splint and Planning Kit, Orthognathic Kit, two Splints
05420060355066Patient Specific Splint, Orthognathic
05420060355059Patient Specific Splint, Orthognathic, Intermediate
05420060353857Anatomical Model for PSI Verification, Skull Only
05420060353840Anatomical Model for PSI Verification, Implant Only
05420060353833Anatomical Model for PSI Verification/MultiPiece-White
05420060353826Anatomical Model for PSI Verification/2 Piece-White
05420060353819Anatomical Model for PSI Verification/1 Piece-White
05420060353703Anatomical Model, Child, Graft Site, White
05420060353697Anatomical Model, Child, Skull, White
05420060353680Anatomical Model, Child, Max - Cranium, White
05420060353673Anatomical Model, Child, Max - Orbit, White
05420060353666Anatomical Model, Child, Mand - Orbit, White
05420060353659Anatomical Model, Child, Mand - Max, White
05420060353642Anatomical Model, Child, Cranial Cap, White
05420060353635Anatomical Model, Child, Orbit, White
05420060353628Anatomical Model, Child, Maxilla, White
05420060353611Anatomical Model, Child, Mandible, White
05420060353390Planned Model, Skull, White
05420060353383Planned Model, Maxilla - Cranium, White
05420060353376Planned Model, Maxilla - Orbit, White
05420060353369Planned Model, Mandible - Orbit, White
05420060353314Planned Model, Mandible, White
05420060353123Anatomical Model, Graft Site, White
05420060353093Anatomical Model, Skull, White
05420060353086Anatomical Model, Maxilla - Cranium, White
05420060353079Anatomical Model, Maxilla - Orbit, White
05420060353062Anatomical Model, Mandible - Orbit, White
05420060353055Anatomical Model, Mandible - Maxilla, White
05420060353048Anatomical Model, Cranial Cap, White
05420060353031Anatomical Model, Orbit, White
05420060353024Anatomical Model, Maxilla, White
05420060353017Anatomical Model, Mandible, White
05420060352713Anatomical Model, Teeth, Clear
05420060352706Anatomical Model, Child, Graft Site, Clear
05420060352690Anatomical Model, Child, Skull, Clear
05420060352683Anatomical Model, Child, Maxilla/Cranium, Clear
05420060352676Anatomical Model, Child, Maxilla - Orbit, Clear
05420060352669Anatomical Model, Child, Mandible - Orbit, Clear
05420060352652Anatomical Model, Child, Mandible/Maxilla, Clear
05420060352645Anatomical Model, Child, Cranial Cap, Clear
05420060352638Anatomical Model, Child, Orbit, Clear
05420060352621Anatomical Model, Child, Maxilla, Clear
05420060352614Anatomical Model, Child, Mandible, Clear
05420060352393Planned Model, Skull, Clear
05420060352386Planned Model, Maxilla - Cranium, Clear
05420060352379Planned Model, Maxilla - Orbit, Clear
05420060352362Planned Model, Mandible - Orbit, Clear
05420060352317Planned Model, Mandible, Clear

Trademark Results [ProPlan CMF]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROPLAN CMF
PROPLAN CMF
87536011 5542380 Live/Registered
DePuy Synthes, Inc.
2017-07-20
PROPLAN CMF
PROPLAN CMF
85203553 4106689 Live/Registered
DEPUY SYNTHES, INC.
2010-12-22

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