FDA.report

RZ Medizintechnik GmbH

Primary DI
04049197188333
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
259-230-004
Catalog number
259-230-004
Device description
McCullouch Ball Probe, 4mm 235mm, 9 1/2"
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
FGMPROBE AND DIRECTOR, GASTRO-UROLOGY

Product Code Classifications

CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049197188333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049197188333040491971883334049197188333

GMDN Terms

TermDefinition
General surgery wound probe/packerA slender, double-ended, hand-held manual surgical instrument intended to be used to explore and examine wounds, and additionally to introduce and pack gauze or dressings into the wound. It consists of a flat blunt blade at one end and a packer at the other end, with the handle formed from its middle section; it is made of metallic and/or synthetic polymer material. This is a single-use 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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04049197178563RZ Medizintechnik GmbH253-000-352253-000-3522025-07-30
04049197178570RZ Medizintechnik GmbH253-000-356253-000-3562025-07-30
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
04049197178839RZ Medizintechnik GmbH253-000-527253-000-5272025-07-30
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