FDA.report

Medicon

Primary DI
04046826072674
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
55.08.21
Catalog number
55.08.21
Device description
Merz aorta punch 21cm 5mm
Published
2020-09-25
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826072674PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826072674040468260726744046826072674

GMDN Terms

TermDefinition
Aorta punch, reusableA manual surgical instrument designed to cut a circular plug of tissue from the wall of the aorta to create an anastomosis site during vascular surgery. It consists of a pointed, cone-shaped, disk-like tip on the end of a plunger that is inserted through a small incision made; its diameter corresponds to the size of the hole. Behind the tip is a thinner section which entraps (holds) the tissue as the sharp circular blade is pressed down the plunger by the surgeon into and through the tissue. It is typically made of high-grade stainless steel and is available in various punch sizes. It can equally be used to punch holes in other vessels if needed. 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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