FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00810799032010
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
S4-1151
Catalog number
S4-1151
Device description
Barraquer Lenticular Spoon
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
HNZCurette, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNZCurette, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810799032010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799032010008107990320108107990320100810799032010

GMDN Terms#

Term, Definition table
TermDefinition
Lens spoonA hand-held ophthalmic surgical instrument used in ophthalmic surgery to manipulate/remove the lens of the eye. It is typically made of high-grade stainless steel and has a spoon-shaped distal working end. 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
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
B382SD9344181000Surgical DirectSurgical Direct, Inc.HNZ2026-07-10
B382SD9344181010Surgical DirectSurgical Direct, Inc.HNZ2026-07-10
B382SD9344181020Surgical DirectSurgical Direct, Inc.HNZ2026-07-10
B382SD9344181030Surgical DirectSurgical Direct, Inc.HNZ2026-07-10
00860015282064Intrace USAPILOTIS TECH LLCHNZ2026-07-03
05060411981133Chalazion Curette 2.5mmDTR MEDICAL LIMITEDHNZ2026-06-10
05060411983823Double Ended Chalazion Curette, 1mm & 2mm ScoopsDTR MEDICAL LIMITEDHNZ2026-06-10
05060411984424Chalazion Curette 3mmDTR MEDICAL LIMITEDHNZ2026-06-10
00757770505708Bausch + LombBausch & Lomb IncorporatedHNZ2026-04-30
04058935013288Terry Scraper Non Irr DSEKBausch & Lomb GmbHHNZ2025-10-26
00190776410780MillenniumAvalign Technologies, Inc.HNZ2025-09-12
00757770636242Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-13
G2231196790Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNZ2025-08-11
00757770407583Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770415199Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770415533Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770419029Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770419401Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770433636Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00757770436385Bausch + LombBausch & Lomb IncorporatedHNZ2025-08-08
00194613005160MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613087142MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613100377MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613101558MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613101572MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613103569MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613108588MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
00194613113988MSI Precision Specialty InstrumentsMed Saver, Inc.HNZ2025-08-01
04058935012663Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10
04058935012670Meyerhoefer Chalazion CuretteBausch & Lomb GmbHHNZ2025-07-10