FDA.reportPublic FDA data

JOTA

Primary DI
EJOT806104166514014
Brand
JOTA
Company
Jota AG
Model
859F.HP.014
Device description
Diamond Podology
Published
2024-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZPInstrument, Diamond, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZPInstrument, Diamond, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EJOT806104166514014PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Podiatric bur, reusableA rotary abrasive device typically used by a podiatrist intended to debride excrescences and treat conditions such as heavy toenails and/or plantar calluses. It consists of a well-differentiated head of various shapes (e.g., cone, cylinder, inverted cone, pear) made of hard materials (e.g., diamond, metal carbide), and a tapered, notched or elongated proximal end intended to fit into an appropriate powered handpiece (not included); it may be composed of two separate pieces. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480670983
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EJOT806313545724S16JOTASL846R.FGS.0162025-11-19
EJOT806314001704S14JOTASL801EF.FG.0142025-11-19
EJOT806314001714S23JOTASL801F.FG.0232025-11-19
EJOT806314001724S10JOTASL801.FG.0102025-11-19
EJOT806314001724S14JOTASL801.FG.0142025-11-19
EJOT806314001724S16JOTASL801.FG.0162025-11-19
EJOT806314001724S18JOTASL801.FG.0182025-11-19
EJOT806314001734S18JOTASL801G.FG.0182025-11-19
EJOT806314001734S23JOTASL801G.FG.0232025-11-19
EJOT806314012724S12JOTASL805.FG.0122025-11-19
EJOT806314012724S16JOTASL805.FG.0162025-11-19
EJOT806314012724S18JOTASL805.FG.0182025-11-19
EJOT806314012734S16JOTASL805G.FG.0162025-11-19
EJOT806314038724S32JOTASL811.FG.0322025-11-19
EJOT806314042724S26JOTASL815.FG.0262025-11-19
EJOT806314068724S42JOTASL909.FG.0422025-11-19
EJOT806314068734S35JOTASL909G.FG.0352025-11-19
EJOT806314068734S42JOTASL909G.FG.0422025-11-19
EJOT806314109724S10JOTASL836.FG.0102025-11-19
EJOT806314111724S12JOTASL837L.FG.0122025-11-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887919227335Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
00887919317036Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029468Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029499Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029529Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029550Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029581Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029611Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029642Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029673Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029703Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029734Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029765Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029796Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029826Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029857Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029888Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029918Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029949Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
08404535029970Brasseler USA Sterile DiamondPeter Brasseler Holdings, LLCDZP2026-05-27
ESUN379P3140215Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2025-04-29
ESUN801C2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2025-04-29
ESUN801F3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801F3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801F3140255Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140185Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801L3140235Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23
ESUN801LC3140145Sunshine DiamondsDr. Hopf GmbH & Co. KGDZP2023-06-23