FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00810799038333
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
SC-1230
Catalog number
SC-1230
Device description
Stephens Handle, Irrigating & Aspirating, Standard
Published
2020-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMXCannula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810799038333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799038333008107990383338107990383330810799038333

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical irrigation/infusion/aspiration handle, reusableA hand-held, manual tubular device designed as an interface between an ophthalmic cannula intended for infusion, irrigation and/or aspiration (e.g., a capsular polishing or a cystotome cannula) and associated tubing, to facilitate manipulation of the cannula. It is typically made of metal or a durable polymer and is in the form a cylinder, that has a Luer fitting at the distal end, for connection to the cannula. It is typically used in cataract surgery. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(859)259-4925info@stephensinst.com

Regulatory Flags#

DUNS number
081853285
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810061912194Stephens Instruments S5-1612S5-16122025-07-23
00810061912606Stephens Instruments S5-1921S5-19212025-07-23
00810061912613Stephens Instruments ST5-1246ST5-12462025-07-23
00810061912620Stephens Instruments ST5-1614ST5-16142025-07-23
00810061910435Stephens InstrumentsST5-7000-23ST5-7000-232020-09-23
00810061910442Stephens InstrumentsST5-7000-25ST5-7000-252020-09-23
00810061910459Stephens InstrumentsST5-7005-23ST5-7005-232020-09-23
00810061910466Stephens InstrumentsST5-7005-25ST5-7005-252020-09-23
00810061910473Stephens InstrumentsST5-7010-23ST5-7010-232020-09-23
00810061910480Stephens InstrumentsST5-7010-25ST5-7010-252020-09-23
00810061910497Stephens InstrumentsST5-7035ST5-70352020-09-23
00810061910510Stephens InstrumentsST5-7050ST5-70502020-09-23
00810061910541Stephens InstrumentsST5-7065ST5-70652020-09-23
00810061910558Stephens InstrumentsST5-7070ST5-70702020-09-23
00810061910503Stephens InstrumentsST5-7040ST5-70402020-09-22
00810061910527Stephens InstrumentsST5-7056ST5-70562020-09-22
00810061910534Stephens InstrumentsST5-7060ST5-70602020-09-22
00810799032928Stephens InstrumentsS4-1490S4-14902020-09-22
00810799031358Stephens InstrumentsS2-1131S2-11312020-09-22
00810799031365Stephens InstrumentsS2-1135S2-11352020-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810163790577Diamatrix Ltd.DiamatrixHMX2026-05-26
00841668145906BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145913BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145920BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145937BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145944BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145951BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146040BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146057BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146088BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146101BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146118BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146125BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146156BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146163BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146187BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146217BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146224BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146255BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668145487BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146286BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146293BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146309BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146316BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146323BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146330BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146347BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146354BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146361BLINKKATENA PRODUCTS, INC.HMX2026-03-23
00841668146378BLINKKATENA PRODUCTS, INC.HMX2026-03-23