FDA.report

Medicon

Primary DI
04046826060312
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
51.56.20
Catalog number
51.56.20
Device description
Guyon kidney fcps 20cm
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
FFNCLAMP, NON-ELECTRICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FFNClamp, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826060312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826060312040468260603124046826060312

GMDN Terms

TermDefinition
Open-surgery stone-retrieval forcepsA hand-held manual surgical instrument designed to grasp and/or manipulate a calculus (i.e., a kidney or gallbladder stone) during an open surgical procedure; additional intended uses may include soft-tissue manipulation (e.g., polyp removal). It is typically made of high-grade stainless steel and is of scissors-like design with two handles attached to two long curved blades. The handles may be permanently joined or conjoined, usually by pressure, during use. The distal gripping blades may be designed with serrated and/or ringed or slotted grasping surfaces. 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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