FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00810799031280
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
S1-1297
Catalog number
S1-1297
Device description
Nasal Speculum, Adult
Published
2020-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00810799031280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799031280008107990312808107990312800810799031280

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. 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
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
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
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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