FDA.report

Ophthalmic Ring

Primary DI
00841668100752
Brand
Ophthalmic Ring
Company
KATENA PRODUCTS, INC.
Model
K1-7140
Catalog number
K1-7140
Device description
FLIERINGA FIXATION RING 14MM
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
HNHRING, OPHTHALMIC (FLIERINGA)

Product Code Classifications

CodeDeviceSpecialtyClass
HNHRing, Ophthalmic (Flieringa)Ophthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841668100752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668100752008416681007528416681007520841668100752

GMDN Terms

TermDefinition
Flieringa ophthalmic ringA circular band, typically stainless steel, sutured to the sclera to prevent collapse of the globe (sphere) during difficult intraocular operations. This is a reusable device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter14Millimeter

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
true
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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