FDA.report

Medicon

Primary DI
04046826097790
Brand
Medicon
Company
Medicon eG. Chirurgiemechaniker-Genossenschaft
Model
60.20.70
Catalog number
60.20.70
Device description
Dix spud a needle 9.5cm
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
HNNKnife, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046826097790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046826097790040468260977904046826097790

GMDN Terms

TermDefinition
Eye spud/needleA hand-held manual ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle in the centre of the instrument. At one end is a thin concave blade with a rounded nose (spud), and at the other end is a spearhead-shaped needle. The ophthalmologist uses these tips to remove the foreign body/object. 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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