FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00810799030900
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
S1-1105
Catalog number
S1-1105
Device description
Guyton-Park Speculum, Solid Blade, Suture Posts on Side
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
HNCSpecula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNCSpecula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810799030900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799030900008107990309008107990309000810799030900

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid speculum, reusableA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. 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
DM exempt
true
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
00810189451681Surgical DesignSurgical Design, Inc.HNC2026-05-23
00810189451698Surgical DesignSurgical Design, Inc.HNC2026-05-23
00810189451711Surgical DesignSurgical Design, Inc.HNC2026-05-23
00757770683741Bausch + LombBausch & Lomb IncorporatedHNC2026-02-04
05056785302988Kratz Plastic Mechanical SpeculumBLINK MEDICAL LIMITEDHNC2026-02-04
05056785303008Plastic Solid Bladed Mechanical SpeculumBLINK MEDICAL LIMITEDHNC2026-02-04
00840319758533Hayden MedicalHayden Medical, Inc.HNC2025-12-31
00840319758380Hayden MedicalHayden Medical, Inc.HNC2025-12-24
00852194002113HAI SpeculaHightech American Industrial Labs IncHNC2025-12-16
00757770652013Bausch + LombBausch & Lomb IncorporatedHNC2025-11-14
05060480409538Speculum LeibingerBLINK MEDICAL LIMITEDHNC2025-09-18
00190776410742MillenniumAvalign Technologies, Inc.HNC2025-09-12
00190776409456MillenniumAvalign Technologies, Inc.HNC2025-09-02
00190776408411MillenniumAvalign Technologies, Inc.HNC2025-08-08
00757770461974Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770481828Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770502462Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770503292Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770636891Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00194613009984MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010058MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010140MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010164MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010171MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010188MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010317MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010331MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010386MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010423MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010447MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01