FDA.report

Corneal Trephine

Primary DI
00841668101636
Brand
Corneal Trephine
Company
KATENA PRODUCTS, INC.
Model
K2-7510
Catalog number
K2-7510
Device description
ELLIOT TREPHINE BLADE 1.5MM
Published
2020-09-14
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
HRHTrephine, manual, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841668101636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668101636008416681016368416681016360841668101636

GMDN Terms

TermDefinition
Corneal trephine, reusableAn ophthalmic surgical blade designed to cut and remove circular sections of the cornea (corneal buttons) and/or sclera from a patient to prepare for graft implantation, or from cadaveric donors to obtain grafts. It is typically a sharp, beveled, hollow cylinder, of different diameters, having a circular, saw-like working edge. It is an exchangeable device that may be attached to a manually rotated handle or to a powered rotary surgical handpiece. This device is typically made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter1.5Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(973)989-1600info@katena.com
+1(973)989-1600inquiries.corzaeye@corza.com

Regulatory Flags

DUNS number
085668598
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
false

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