FDA.report

Stephens Instruments

Primary DI
00810799033765
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
S5-1210
Catalog number
S5-1210
Device description
Cohan Corneal Forceps
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

Related Records

Contact Domains

Product Codes

CodeName
HNRForceps, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810799033765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799033765008107990337658107990337650810799033765

GMDN Terms

TermDefinition
Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusableA hand-held manual surgical instrument designed to facilitate the grasping, manipulation, or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design with variously designed tips, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a reusable device intended to be sterilized prior to use.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
24026704941661PILLINGTELEFLEX INCORPORATEDHNR2026-03-23
G346EA0323SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-03-12
00840319758854Hayden MedicalHayden Medical, Inc.HNR2026-03-06
00190776417659MillenniumAvalign Technologies, Inc.HNR2026-03-04
74546951616426MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951616433MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951616440MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951619090MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951619106MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635595MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635601MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635618MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635625MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635632MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635649MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635656MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635663MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635670MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635687MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635694MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635700MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635717MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635724MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635731MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635748MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635755MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635762MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635779MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635786MANI MICRO FORCEPSMANI, INC.HNR2026-03-03
74546951635793MANI MICRO FORCEPSMANI, INC.HNR2026-03-03