FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00810799035172
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
S5-1815
Catalog number
S5-1815
Device description
Artisan Lens Implantation 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
00810799035172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799035172008107990351728107990351720810799035172

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic implant handling forceps, reusableA hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.

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
00757770602506Bausch + LombBausch & Lomb IncorporatedHNR2026-10-09
00190776436209MillenniumAvalign Technologies, Inc.HNR2026-10-08
00190776433734MillenniumAvalign Technologies, Inc.HNR2026-10-07
00190776436155MillenniumAvalign Technologies, Inc.HNR2026-10-07
0081748902541323ga DEX™ Morris ILM ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620361525ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620509125ga DEX Stiff NanoTapered Awh ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620510725ga DEX Stiff Morris Honey Badger ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620511425ga DEX Stiff Asymmetrical Tano ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620512125ga (0.50mm) Dex™ Stiff Serrated Jaw ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620513825ga DEX Stiff Maculorhexis ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620514525ga DEX Stiff End Grasper ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620515225ga DEX Stiff Morris ILM ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620516925ga DEX™ Stiff Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
G223M111991S0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-10-01
00190776432942MillenniumAvalign Technologies, Inc.HNR2026-09-30
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