FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00810799039460
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
SSD4 1387
Catalog number
SSD4 1387
Device description
Sinskey II Lens Hook, Micro, Angled, Round Handle, 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
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNQHook, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810799039460PackageGS110In Commercial Distribution
00810799039477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799039460008107990394608107990394600810799039460
00810799039477008107990394778107990394770810799039477

GMDN Terms#

Term, Definition table
TermDefinition
Ocular hook/spatula/manipulator, single-useA hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation/implantation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00810061911531Stephens Instruments S9-1800S9-18002024-02-23
00810061911548Stephens Instruments S9-1805S9-18052024-02-23
00810061911555Stephens Instruments S9-1900S9-19002024-02-23
00810061911562Stephens Instruments S9-1905S9-19052024-02-23
00810061911869Stephens Instruments S1-1005HS1-1005H2024-02-23
00810061911876Stephens Instruments S4-1458S4-14582024-02-23
00810061911999Stephens Instruments S4-1575S4-15752024-02-23
00810061912002Stephens Instruments S5-1350S5-13502024-02-23
00810061912019Stephens Instruments S5-1351S5-13512024-02-23
00810061912026Stephens Instruments ST4-1555ST4-15552024-02-23
00810061912033Stephens Instruments ST4-1575ST4-15752024-02-23
00851807007958Stephens Instruments S4-1350S4-13502024-02-23
00810061911944SUMMIT MEDICAL200320032024-01-12
00810061911951SUMMIT MEDICAL200520052024-01-12
00810061911968SUMMIT MEDICAL200820082024-01-12
00810061911975SUMMIT MEDICAL201020102024-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417581MillenniumAvalign Technologies, Inc.HNQ2026-03-04
00810123209828Adler Instrument CompanyAdler, Inc.HNQ2026-02-10
00190776415662MillenniumAvalign Technologies, Inc.HNQ2026-02-02
00840319758663Hayden MedicalHayden Medical, Inc.HNQ2026-01-30
00190776415211MillenniumAvalign Technologies, Inc.HNQ2026-01-27
00840319758557Hayden MedicalHayden Medical, Inc.HNQ2025-12-31
G2231394680Sinskey lens manipulating hookMedetz Surgical Instruments LLCHNQ2025-12-16
00852194002076HAI HookHightech American Industrial Labs IncHNQ2025-12-15
09348811119902INKAThe Trustee for KAISER FAMILY TRUSTHNQ2025-12-03
00757770636228Bausch + LombBausch & Lomb IncorporatedHNQ2025-11-14
00757770645732Bausch + LombBausch & Lomb IncorporatedHNQ2025-09-12
00757770683666Bausch + LombBausch & Lomb IncorporatedHNQ2025-09-12
00840319758250Hayden MedicalHayden Medical, Inc.HNQ2025-09-12
00840319758229Hayden MedicalHayden Medical, Inc.HNQ2025-08-29
00757770421701Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-22
00757770636884Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-14
00757770673964Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-14
G22312244990Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
G2231458300Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
G223997034050Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2025-08-11
00757770478613Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770507481Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770510962Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770535514Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00757770535682Bausch + LombBausch & Lomb IncorporatedHNQ2025-08-08
00194613004224MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004446MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004453MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004583MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01
00194613004590MSI Precision Specialty InstrumentsMed Saver, Inc.HNQ2025-08-01