OP 3D Carpus Holder

GUDID 06430035874484

Carpus holder for Carpus imaging with Orthopantomograph OP 3D

PaloDEx Group Oy

Limited-view-field CT system
Primary Device ID06430035874484
NIH Device Record Key3c393923-d76d-4650-92d7-a1f3b026c7be
Commercial Distribution StatusIn Commercial Distribution
Brand NameOP 3D Carpus Holder
Version Model Number901074
Company DUNS459955188
Company NamePaloDEx Group Oy
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106430035874484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IWYHolder, Head, Radiographic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-04
Device Publish Date2021-05-27

Devices Manufactured by PaloDEx Group Oy

06430035872947 - OCCLUSAL 4C START-UP KIT2024-07-25 OCCLUSAL 4C START-UP KIT
06430035875177 - ORTHOPANTOMOGRAPH™ OP 3D2024-05-14 ORTHOPANTOMOGRAPH™ OP 3D EX (PAN 3D)
06430035875139 - ORTHOPANTOMOGRAPH™ OP 3D2024-03-22 OP 3D LX CEPH UPGRADE KIT
06430035875092 - ORTHOPANTOMOGRAPH™ OP 3D2023-10-10 ORTHOPANTOMOGRAPH™ OP 3D LX (PAN 3D)
06430035875108 - ORTHOPANTOMOGRAPH™ OP 3D2023-10-10 ORTHOPANTOMOGRAPH™ OP 3D LX (PAN, CEPH 3D)
06430035873630 - Orthopantomograph OP 3D2021-06-08
06430035874484 - OP 3D Carpus Holder2021-06-04Carpus holder for Carpus imaging with Orthopantomograph OP 3D
06430035874484 - OP 3D Carpus Holder2021-06-04 Carpus holder for Carpus imaging with Orthopantomograph OP 3D
06430035874354 - Bite blocks 10pcs OP 3D2021-06-03

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