FDA.report

Medicon

Primary DI
04046826058227
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
51.06.00
Catalog number
51.06.00
Device description
set of 13 Bakes dilators 1-13mm
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
FGMPROBE AND DIRECTOR, GASTRO-UROLOGY

Product Code Classifications

CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826058227PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826058227040468260582274046826058227

GMDN Terms

TermDefinition
Common bile duct probeA hand-held manual surgical instrument designed as a slender rod made of flexible metal with a blunt bulbous tip, used for exploring the common bile duct, i.e., the union of the cystic and hepatic ducts. It is used in surgical procedures to explore and/or dilate strictures of the common duct. 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
false
Serial number
true
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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