FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00810799039828
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
SSD7 1085
Catalog number
SSD7 1085
Device description
Stevens Tenotomy Scissors, Straight, 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
HNFSCISSORS, OPHTHALMIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810799039828PackageGS110In Commercial Distribution
00810799039835PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799039828008107990398288107990398280810799039828
00810799039835008107990398358107990398350810799039835

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular scissors, conventional-hinge, single-useA hand-held manual ophthalmic surgical instrument intended to be used to cut intraocular tissue of the anterior segment (e.g., iris). It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic, may have ring handles or sprung handles, and is available with various blade designs and sizes. 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
00810220800201Adler Instrument CompanyAdler, Inc.HNF2026-05-26
00192896122833Intraocular SetSONTEC INSTRUMENTS, INC.HNF2026-03-19
00198506089602ELMED INCORPORATEDELMED INCORPORATEDHNF2026-03-17
00192896122819Reynolds Tenotomy ScissorsSONTEC INSTRUMENTS, INC.HNF2026-03-10
00840319758366Hayden MedicalHayden Medical, Inc.HNF2025-12-24
00840319758373Hayden MedicalHayden Medical, Inc.HNF2025-12-24
G2231135500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2025-12-16
G2231135900Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2025-12-16
00852194002045HAI ScissisorsHightech American Industrial Labs IncHNF2025-12-15
04059453156839Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
04059453161697Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
04059453162632Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
00190776415167MillenniumAvalign Technologies, Inc.HNF2025-12-03
09348811004185INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-12-02
04059453117205Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-09-25
04059453119780Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-08-25
00757770406401Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770419197Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770423040Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770417780Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770483563Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770483570Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770486175Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770492350Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770510603Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00194613003784MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613003791MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004101MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004316MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004682MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01