FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00810799035158
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
S5-1804
Catalog number
S5-1804
Device description
Humer Lens Folding Forceps
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
HNRForceps, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810799035158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799035158008107990351588107990351580810799035158

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular lens folderA hand-held, sterile, device designed to uniformly fold a foldable intraocular lens (IOL) in order to reduce its natural physical size so that the IOL can be removed from the IOL folder with an implantation forceps and be implanted into the anterior or posterior chamber of the eye through a small incision during ophthalmic surgery. It is typically made of synthetic material (e.g., polypropylene) and is designed to accept the IOL in its natural unfolded state, when in place the operator activates the folding 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
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
04059453116635Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNR2026-08-25
00190776426576MillenniumAvalign Technologies, Inc.HNR2026-08-19
00190776426774MillenniumAvalign Technologies, Inc.HNR2026-08-19
00198506093975ELMED INCORPORATEDELMED INCORPORATEDHNR2026-08-18
G346EA41HSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-08-14
00190776411480MillenniumAvalign Technologies, Inc.HNR2026-08-07
00860013297954Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNR2026-08-07
B382SD9028531640Surgical DirectSurgical Direct, Inc.HNR2026-08-07
G22312552000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-08-03
00840319759202Hayden MedicalHayden Medical, Inc.HNR2026-07-30
G2231114060Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G2231119000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G223111901T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G22312408910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
00190776405854MillenniumAvalign Technologies, Inc.HNR2026-07-26
00190776405878MillenniumAvalign Technologies, Inc.HNR2026-07-26
00190776398675MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776403690MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776403737MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776398668MillenniumAvalign Technologies, Inc.HNR2026-07-16
00190776398699MillenniumAvalign Technologies, Inc.HNR2026-07-16
00860015282002Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282019Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282026Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282033Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282071Intrace USAPILOTIS TECH LLCHNR2026-07-03
00840285320789Walcott Rx ProductsWalcott Rx Product IncHNR2026-06-05
G006D35072330AKAHOSHI SUPER COMBO III PRECHOPPERDAUD JEE MFG. COHNR2022-12-19
G006D50171630CORYDON FORCEPS EROGONOMIC ROUND HANDLEDAUD JEE MFG. COHNR2022-12-17
G006D5011895010COLIBRI FORCEP 0.12 W/TYING PLATFORMDAUD JEE MFG. COHNR2022-12-13