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
00724995317973V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318024V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318246V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318253V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318284V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318307V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318338V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318345V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318451V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318468V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318475V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318482V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318499V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318598V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318673V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318680V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318697V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318703V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318741V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318772V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318833V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318857V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318932V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318949V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995317980V. MuellerSteris CorporationHNR2026-09-24
00724995318321V. MuellerSteris CorporationHNR2026-09-24
00724995318413V. MuellerSteris CorporationHNR2026-09-24
00724995318420V. MuellerSteris CorporationHNR2026-09-24
00724995318437V. MuellerSteris CorporationHNR2026-09-24
00724995318444V. MuellerSteris CorporationHNR2026-09-24