FDA.report

RZ Medizintechnik GmbH

Primary DI
04049197477697
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
430-355-000
Catalog number
430-355-000
Device description
Holder for mouth gag, complete 2 bars, plate for mouth gag fixation
Published
2024-09-20
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
GZXINSTRUMENT, MICROSURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049197477697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049197477697040491974776974049197477697

GMDN Terms

TermDefinition
Mouth gag support, reusableA non-sterile frame-like device intended to support a mouth gag over/near a patient’s mouth during dental, anaesthesia, or ENT procedures. It consists of three interlocking components: a strip with a central line of holes and two rods with rings at one end which can be aligned to accept the supporting hook of the mouth gag. Otherwise known as a Draffin Bipod, the arrangement provides a configurable support at variable heights. This is a reusable device.

Sterilization Methods

Method

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
false

Other Devices From This Company

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04049197178150RZ Medizintechnik GmbH253-000-210253-000-2102025-07-30
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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
04049197178822RZ Medizintechnik GmbH253-000-524253-000-5242025-07-30
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