FDA.report

MEYERHOEFER CHALAZION CURETTE 3.50MM

Primary DI
00841668128237
Brand
MEYERHOEFER CHALAZION CURETTE 3.50MM
Company
KATENA PRODUCTS, INC.
Model
AE-2004
Catalog number
AE-2004
Device description
MEYERHOEFER CHALAZION CURETTE 3.50MM
Published
2022-12-07
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
HNZCurette, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNZCurette, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841668128237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668128237008416681282378416681282370841668128237

GMDN Terms

TermDefinition
Corneal trephine handleA hand-held, ophthalmic surgical device used to hold an exchangeable trephine (cylindrical cutting blade) so that it can be manually rotated with downward pressure by a surgeon in order to cut and remove circular pieces of corneal tissue (corneal buttons) or scleral tissue. It is typically made of high-grade stainless steel and may have a knurled portion on the shaft to provide a grip. This is a reusable device.

Device Sizes

TypeValueUnit
Outer Diameter3.5Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+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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