FDA.report

N.A.

Primary DI
04049368069553
Brand
N.A.
Company
Geuder Aktiengesellschaft
Model
18235
Catalog number
18235
Device description
N.A.
Published
2021-02-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HNJPunch, corneo-scleral

Product Code Classifications

CodeDeviceSpecialtyClass
HNJPunch, Corneo-ScleralOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049368069553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049368069553040493680695534049368069553

GMDN Terms

TermDefinition
Corneal punch setA collection of surgical instruments intended to cut a precise circular section of the cornea (corneal button) from stored cadaveric donor tissue for transplantation into a prepared patient. It typically consists of a small base plate, an extremely sharp and hollow cylinder that has a thin circular cutting edge (a trephine), and a guide through which the trephine can travel. The surgeon typically places a section of corneal tissue into the centre of the base plate (it has a graduated inverse bowl emulating the curvature of the eye), assembles the guide and trephine into position, and applies pressure onto the trephine to cut the button. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
316267202
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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