FDA.report

RZ Medizintechnik GmbH

Primary DI
04049197307482
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
410-276-074
Catalog number
410-276-074
Device description
Hartmann eustachian catheter Ø2.5 mm
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JZFTUBE, EAR SUCTION

Product Code Classifications

CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049197307482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049197307482040491973074824049197307482

GMDN Terms

TermDefinition
Eustachian catheter, reusableA long, flexible tube used for middle ear drainage and/or temporary equalization of the pressure on both sides of the eardrum via insufflation. The distal tip is passed along the floor of the nose and guided into the Eustachian tube; air may be blown from an external bag through the device and into the middle ear. It is typically made of soft metals [e.g., silver (Ag) coated brass], and has a curved distal end with a slightly bulbous tip and a wider funnel-like proximal end with a finger ring to aid manipulation. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+49746294700info@rz-medizintechnik.com

Regulatory Flags

DUNS number
312953227
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

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04049197178723RZ Medizintechnik GmbH253-000-358253-000-3582025-07-30
04049197178730RZ Medizintechnik GmbH253-000-366253-000-3662025-07-30
04049197178747RZ Medizintechnik GmbH253-000-368253-000-3682025-07-30
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