FDA.reportPublic FDA data

egger A/ITE vario

Primary DI
D239206411
Brand
egger A/ITE vario
Company
Innovation MediTech GmbH
Model
20641
Catalog number
20641
Device description
No.
Published
2025-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDGKit, Earmold, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDGKit, Earmold, ImpressionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D239206411PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Earmould impression kitA collection of non-sterile supplies, instruments, and materials intended to be used to make an accurate impression of the folds and convolutions of cartilage that form the outer ear and its canal (i.e., an earmould). It typically includes a foam or cotton block, a mixing bowl, a spatula, impression liquid and/or powder; it also includes either a syringe or tube to deliver the impression material, or less frequently an impression tray for direct moulding. The mould of the ear is used to manufacture custom-made hearing devices such as hearing aids and earplugs. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49230388070info@dreve.de

Regulatory Flags#

DUNS number
313785693
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E2392064111egger A/ITE vario2064112064112025-08-29
E239M700101VITA ENAMIC GLAZE1M700102016-10-18
E239M700111VITA ENAMIC STAINS LIQUID1M700112016-10-18
E239M7001211VITA ENAMIC STAIN white1M7001212016-10-18
E239M7001221VITA ENAMIC STAIN corn1M7001222016-10-18
E239M7001231VITA ENAMIC STAIN brown1M7001232016-10-18
E239M7001241VITA ENAMIC STAIN blue1M7001242016-10-18
E239M7001251VITA ENAMIC STAIN black1M7001252016-10-18
E239M7001261VITA ENAMIC STAIN khaki1M7001262016-10-18
E239M1113001 Sonopal® hard Lacquer AlM111300M1113002020-09-21
E239M1113031Sonopal® hard Lacquer Al M111303M1113032020-09-21
E239M1113041Sonopal® hard Lacquer AlM111304M1113042020-09-21
E239M1113091Sonopal® hard Lacquer AlM111309M1113092020-09-21
E239M1115041Sonopal® soft Lacquer EM111504M1115042020-09-21
E239M1115051Sonopal® soft Lacquer EM111505M1115052020-09-21
E239M1115071Sonopal® soft Lacquer EM111507M1115072020-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00365044000080ComforTen® 60-hole covered trayJubilant Hollisterstier LLCLDG2026-03-02
E2392064111egger A/ITE varioInnovation MediTech GmbHLDG2025-08-29
E2392936M1Otoform® A flexDreve Otoplastik GmbHLDG2025-01-20
E2392956M1Otoform® A softXDreve Otoplastik GmbHLDG2025-01-20
E2393206M1Otoform® A softDreve Otoplastik GmbHLDG2025-01-20
E2395041Otoform® KcDreve Otoplastik GmbHLDG2025-01-13
E2398802AU1Otoform® A softX Dreve Otoplastik GmbHLDG2024-03-13
E2398802ST1Otoform® A softX Dreve Otoplastik GmbHLDG2024-03-13
E2398802M1Otoform® A softXDreve Otoplastik GmbHLDG2023-12-18
E23988021Otoform® A softX Dreve Otoplastik GmbHLDG2023-10-31
EPRCA0010200otosil IS-2pro3dure medical GmbHLDG2023-10-18
EPRCA0011000otosil PS-1pro3dure medical GmbHLDG2023-10-18
00850047788153Silicone SINGLES 24 PackWestone Laboratories, Inc.LDG2023-08-25
00850047788160Silicone SINGLES 100 PackWestone Laboratories, Inc.LDG2023-08-25
00850047788177Pink Silicast Westone Laboratories, Inc.LDG2023-08-25
00850047788184Pink SilicastWestone Laboratories, Inc.LDG2023-08-25
00850047788191EZ Mold Singles 24 Pk BlackWestone Laboratories, Inc.LDG2023-08-25
00850047788207EZ Mold Singles 24 Pk BeigeWestone Laboratories, Inc.LDG2023-08-25
00850047788214EZ Mold Singles 24 Pk PinkWestone Laboratories, Inc.LDG2023-08-25
00850047788221EZ Mold Singles 24 Pk PurpleWestone Laboratories, Inc.LDG2023-08-25
00850047788238EZ Mold Singles 24 Pk OrangeWestone Laboratories, Inc.LDG2023-08-25
00850047788245EZ Mold Singles 24 Pk YellowWestone Laboratories, Inc.LDG2023-08-25
00850047788252EZ Mold Singles 24 Pk GreenWestone Laboratories, Inc.LDG2023-08-25
00850047788269EZ Mold Singles 24 Pk BlueWestone Laboratories, Inc.LDG2023-08-25
00850047788276EZ Mold Singles 24 Pk BrownWestone Laboratories, Inc.LDG2023-08-25
00850047788283EZ Mold Singles 24 Pk RedWestone Laboratories, Inc.LDG2023-08-25
00850047788290EZ Mold Singles 24 Pk Forest Green Westone Laboratories, Inc.LDG2023-08-25
00850047788306EZ Mold Singles 22 Pk AssortedWestone Laboratories, Inc.LDG2023-08-25
00850047788313EZ Mold 8oz Tub Set BlackWestone Laboratories, Inc.LDG2023-08-25
00850047788320EZ Mold 8oz Tub Set BeigeWestone Laboratories, Inc.LDG2023-08-25