CRANEX 3D PAN ACCESSORIES

GUDID 06430035874439

PaloDEx Group Oy

Seizure bite block
Primary Device ID06430035874439
NIH Device Record Keyd1394f9c-3fea-49b0-974f-dafb08dd78b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCRANEX 3D PAN ACCESSORIES
Version Model Number900388
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
GS106430035874439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EHAAligner, Beam, X-Ray

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-03
Device Publish Date2021-05-26

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 Holder2021-06-04 Carpus holder for Carpus imaging with Orthopantomograph OP 3D
06430035874354 - Bite blocks 10pcs OP 3D2021-06-03

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