FDA.report

Medicon

Primary DI
04046826067106
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
52.40.01
Catalog number
52.40.01
Device description
Sims uter sound mall grad cm 32cm
Published
2020-09-24
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
HHMSOUND, UTERINE

Product Code Classifications

CodeDeviceSpecialtyClass
HHMSound, UterineObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826067106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826067106040468260671064046826067106

GMDN Terms

TermDefinition
Urethral sound, reusableA hand-held manual surgical instrument designed to explore and measure the urethra. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+490746220090sales@medicon.de

Regulatory Flags

DUNS number
315492330
Device count
1
DM exempt
true
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
false
Sterilization required before use
true

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04049047064725GimmiGimmi GmbHHHM2025-05-20
04049047064923GimmiGimmi GmbHHHM2025-05-20
04049047045267GimmiGimmi GmbHHHM2025-05-14
04049047045328GimmiGimmi GmbHHHM2025-05-14
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