FDA.report

Medicon

Primary DI
04046826068530
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
52.71.04
Catalog number
52.71.04
Device description
Schroeder uter scoop rigid 30cm fig 4
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
HCYCURETTE, UTERINE

Product Code Classifications

CodeDeviceSpecialtyClass
HCYCurette, UterineObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826068530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826068530040468260685304046826068530

GMDN Terms

TermDefinition
Intrauterine scoopA heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long shaft that is used to access and scrape (gouge or scoop out) a particular area of the lining of the uterus for its removal during a gynaecological procedure. The device is rigid and typically made of high-grade stainless steel. The scoop at the distal end is available in various shapes and sizes; there is a handle at the proximal end. 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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