FDA.report

Otoform® Xpand

Primary DI
E2392966M1
Brand
Otoform® Xpand
Company
Dreve Otoplastik GmbH
Model
2966M
Catalog number
2966M
Device description
No.
Published
2022-08-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LDGKit, earmold, impression

Product Code Classifications

CodeDeviceSpecialtyClass
LDGKit, Earmold, ImpressionEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E2392966M1PrimaryHIBCC0

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius28 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+49230388070otoplastik@dreve.de

Regulatory Flags

DUNS number
315808340
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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E239906001FotoTec® DLP.C90600906002026-01-15
E239903001FotoTec® DLP.C90300903002025-07-09
E239908001FotoTec® DLP.C90800908002025-07-09
E2399095011FotoTec® DLP.C9095019095012025-07-09
E239901001FotoTec® DLP.C90100901002025-04-02
E2392936M1Otoform® A flex2936M2936M2025-01-20
E2392956M1Otoform® A softX2956M2956M2025-01-20
E2393206M1Otoform® A soft3206M3206M2025-01-20
E23904171101Pre-bent tubing041711004171102025-01-13
E23904171501Pre-bent tubing041715004171502025-01-13
E239042501Pre-bent tubing04250042502025-01-13
E23911311Silicone tubing113111312025-01-13
E23920211Silicone tubing202120212025-01-13
E2392291001Arc tubing connection2291002291002025-01-13
E239229101Arc tubing connection22910229102025-01-13
E239234101Pre-bent tubing23410234102025-01-13
E2395041Otoform® Kc5045042025-01-13

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E2392956M1Otoform® A softXDreve Otoplastik GmbHLDG2025-01-20
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E2395041Otoform® KcDreve Otoplastik GmbHLDG2025-01-13
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