FDA.report

Medicon

Primary DI
04046826059682
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
51.14.07
Catalog number
51.14.07
Device description
Desjardins gall stone scoop 30cm fig 2
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
FHLSCOOP

Product Code Classifications

CodeDeviceSpecialtyClass
FHLScoopGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826059682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826059682040468260596824046826059682

GMDN Terms

TermDefinition
Gastro-urological scoopA heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long thin shaft that is used to access and scrape tissue from the common hepatic/bile duct system during a gastroenterological/urological (GU) procedure. The device is typically made of high-grade stainless steel and has a malleable (bendable) distal tip to assist with accessibility to the various sites; it has a handle at the proximal end. The scoop is available in various shapes and sizes. 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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