FDA.reportPublic FDA data

DISPOSABLE PLASTIC BAGS SIZE 0 DIGORA OPTIME 100 PCS

Primary DI
06430035873043
Brand
DISPOSABLE PLASTIC BAGS SIZE 0 DIGORA OPTIME 100 PCS
Company
PaloDEx Group Oy
Model
9802389
Published
2020-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
PEMDental Barriers And Sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133231000DIGORA OPTIMEInstrumentarium Dental, Palodex Group OY2014-03-20MUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035873043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035873043064300358730436430035873043

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-use, non-sterileA non-sterile flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is not a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
459955188
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430035873371OCCLUSAL 4C KIT SCAN EXAM900801-DEX2026-06-22
06430035874637Imaging Plates901256-PTU2024-02-22
06430035874644Imaging Plates901257-PTU2024-02-22
06430035874651Imaging Plates901258-PTU2024-02-22
06430035874668Imaging Plates901259-PTU2024-02-22
06430035874675Imaging Plates901248-PTU2024-02-22
06430035874682Imaging Plates901249-PTU2024-02-22
06430035874699Imaging Plates901250-PTU2024-02-22
06430035874705Imaging Plates901251-PTU2024-02-22
06430035874996Imaging Plates901244-PTU2024-02-22
06430035875009Imaging Plates901245-PTU2024-02-22
06430035875016Imaging Plates901246-PTU2024-02-22
06430035875023Imaging Plates901247-PTU2024-02-22
06430035875030Imaging Plates901252-PTU2024-02-22
06430035875047Imaging Plates901253-PTU2024-02-22
06430035875054Imaging Plates901254-PTU2024-02-22
06430035875061Imaging Plates901255-PTU2024-02-22
06430035873357COMFORT OCCLUSAL 4C ACCESSORY KIT900320-PTU900320-PTU2025-12-23
06430035873388OCCLUSAL 4C REFILL KIT900802-DEX2025-12-23
06430035875191ORTHOPANTOMOGRAPH™ OP 3DPCX-1901308-PTU2025-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456214459JMUJMU DENTAL, INCPEM2026-07-10
00840456214466JMUJMU DENTAL, INCPEM2026-07-10
00840456214473JMUJMU DENTAL, INCPEM2026-07-10
00840456214480JMUJMU DENTAL, INCPEM2026-07-10
00840456214497JMUJMU DENTAL, INCPEM2026-07-10
00840456214503JMUJMU DENTAL, INCPEM2026-07-10
00840456217931JMUJMU DENTAL, INCPEM2026-07-10
00840456217948JMUJMU DENTAL, INCPEM2026-07-10
00840456217955JMUJMU DENTAL, INCPEM2026-07-10
00840456217962JMUJMU DENTAL, INCPEM2026-07-10
00840456217979JMUJMU DENTAL, INCPEM2026-07-10
00840456217986JMUJMU DENTAL, INCPEM2026-07-10
00840456214305JMUJMU DENTAL, INCPEM2026-07-06
00840456214312JMUJMU DENTAL, INCPEM2026-07-06
00840456214329JMUJMU DENTAL, INCPEM2026-07-06
00840456214336JMUJMU DENTAL, INCPEM2026-07-06
00840456214343JMUJMU DENTAL, INCPEM2026-07-06
00840456214350JMUJMU DENTAL, INCPEM2026-07-06
00840456214367JMUJMU DENTAL, INCPEM2026-07-06
00840456214374JMUJMU DENTAL, INCPEM2026-07-06
00840456214381JMUJMU DENTAL, INCPEM2026-07-06
00840456214398JMUJMU DENTAL, INCPEM2026-07-06
00840456214404JMUJMU DENTAL, INCPEM2026-07-06
00840456214411JMUJMU DENTAL, INCPEM2026-07-06
00840456214428JMUJMU DENTAL, INCPEM2026-07-06
00840456214435JMUJMU DENTAL, INCPEM2026-07-06
00840456214442JMUJMU DENTAL, INCPEM2026-07-06
00840456215265JMUJMU DENTAL, INCPEM2026-07-06
00840456215746JMUJMU DENTAL, INCPEM2026-07-06
00840456217184JMUJMU DENTAL, INCPEM2026-07-06