FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00810799039996
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
SSD9 1601
Catalog number
SSD9 1601
Device description
Berkeley Double Marker 3.0mm & 3.5mm, Single use, 10/Box
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMQMarker, sclera

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMQMarker, ScleraOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810799039989PackageGS110In Commercial Distribution
00810799039996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799039989008107990399898107990399890810799039989
00810799039996008107990399968107990399960810799039996

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, single-useA manual instrument intended to be used to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device typically with a weighted self-levelling mechanism. This is a single-use device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
081853285
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
00757770498758Bausch + LombBausch & Lomb IncorporatedHMQ2025-08-04
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00194613084059MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086541MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086558MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086565MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613086572MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613087197MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613087487MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613087524MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613099817MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613101473MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613110345MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613110659MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111151MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111304MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613111526MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613121372MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613121426MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00194613123697MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-08-01
00810123483662Vortex Surgical Inc.Vortex Surgical, Inc.HMQ2025-04-18
00810123483655Vortex Surgical Inc.Vortex Surgical, Inc.HMQ2025-04-18
00194613086534MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613087265MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613109660MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613111168MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613111892MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2025-03-21
00194613040918MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040925MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15
00194613040932MSI Precision Specialty InstrumentsMed Saver, Inc.HMQ2024-08-15