FDA.reportPublic FDA data

Sphere Introducer

Primary DI
00841668110836
Brand
Sphere Introducer
Company
KATENA PRODUCTS, INC.
Model
K8-6000
Catalog number
K8-6000
Device description
CARTER SPHERE INTRODUCER
Published
2020-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNPIntroducer, sphere

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNPIntroducer, SphereOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841668110836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841668110836008416681108368416681108360841668110836

GMDN Terms#

Term, Definition table
TermDefinition
Orbital sphere implant introducerA hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
085668598
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841668146460BarronK20-2165K20-21652026-06-10
00841668146484BarronK20-2167K20-21672026-06-10
00841668146491BarronK20-2170K20-21702026-06-10
00841668146507BarronK20-2172K20-21722026-06-10
00841668146514BarronK20-2175K20-21752026-06-10
00841668146521BarronK20-2177K20-21772026-06-10
00841668146538BarronK20-2180K20-21802026-06-10
00841668146545BarronK20-2182K20-21822026-06-10
00841668146552BarronK20-2185K20-21852026-06-10
00841668146569BarronK20-2187K20-21872026-06-10
00841668146576BarronK20-2195K20-21952026-06-10
00841668146590BarronK20-2190K20-21902026-06-10
00841668146606BarronK20-2192K20-21922026-06-10
00841668144299KatenaK3-9258K3-92582026-03-31
00841668144305KatenaK3-9259K3-92592026-03-31
00841668144312KatenaK3-9261K3-92612026-03-31
00841668144329KatenaK3-9262K3-92622026-03-31
00841668144336KatenaK3-9263K3-92632026-03-31
00841668144343KatenaK3-9264K3-92642026-03-31
00841668144350KatenaK3-9265K3-92652026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613011734MSI Precision Specialty InstrumentsMed Saver, Inc.HNP2025-03-21
00757770408320Bausch + LombBausch & Lomb IncorporatedHNP2024-11-20
00887482040010Symmetry FoxASPEN SURGICAL PRODUCTS, INC.HNP2024-08-20
00190776360276MillenniumAvalign Technologies, Inc.HNP2023-02-22
14026704802262PILLINGTELEFLEX INCORPORATEDHNP2022-12-08
54026704802260PILLINGTELEFLEX INCORPORATEDHNP2022-12-08
00842331166532Novo Surgical Inc. NOVO SURGICAL, INC.HNP2022-11-13
00190776072155AvalignAvalign Technologies, Inc.HNP2021-11-03
13760087126386SPHERE INTRODUCERFCI S A S FCI 20 22HNP2021-05-30
00190660109325Ambler SurgicalAMBLER SURGICAL CORP.HNP2021-01-07
04046964686665AESCULAPAESCULAP, INC.HNP2020-08-25
03760087126389Orbital sphere implant introducerFCI S A S FCI 20 22HNP2020-02-26
00192896019317CARTER SPHERE INTRODUCERSONTEC INSTRUMENTS, INC.HNP2018-09-14
05060171621850Orbital Implant InserterCERAMISYS LTDHNP2015-07-31