Chin Support Disposable Cover

GUDID 06430035873401

PaloDEx Group Oy

Medical equipment drape, single-use, non-sterile
Primary Device ID06430035873401
NIH Device Record Keyca7bcb66-a6b7-4055-b324-121b1305cd78
Commercial Distribution StatusIn Commercial Distribution
Brand NameChin Support Disposable Cover
Version Model Number900509
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 Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
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
GS106430035873401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PEMDental Barriers And Sleeves

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-02-01

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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