FDA.reportPublic FDA data

Stephens Instruments

Primary DI
00851807007231
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
ESP-1005
Catalog number
ESP-1005
Device description
Vera90 Synthetic Extended Inserts - 0.5mm
Published
2020-12-20
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
LZUPlug, punctum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZUPlug, PunctumUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020882000SHARPOINT ULTRAPLUG EXTENDED WEAR PLUGSurgical Specialties Corp2002-07-26LZU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851807007231PackageGS110In Commercial Distribution
00810061910954PrimaryGS10
00810061911029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851807007231008518070072318518070072310851807007231
00810061910954008100619109548100619109540810061910954
00810061911029008100619110298100619110290810061911029

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal punctum plugA sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. 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
2
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
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
00385640072403Quintess®Summit Medical, Inc.LZU2026-05-13
00385640072410Quintess®Summit Medical, Inc.LZU2026-05-13
00385640089562Summit MedicalSummit Medical, Inc.LZU2025-12-29
00385640089579Summit MedicalSummit Medical, Inc.LZU2025-12-29
00840277405098Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
00840277405104Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
00840277405111Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
00840277405128Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405095Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405101Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405118Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
10840277405125Lacrimal PlugRIVERPOINT MEDICAL, LLCLZU2024-10-16
08800024300009Hello, eyesBio Optics Co., LtdLZU2024-07-30
08800024300016Hello, eyesBio Optics Co., LtdLZU2024-07-30
08800024300672Hello, eyesBio Optics Co., LtdLZU2024-07-30
00810061911197SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911203SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911210SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911227SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911234SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911241SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911258SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911265SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911944SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911951SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911968SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911975SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911982SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911913SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12
00810061911920SUMMIT MEDICALKRISHNA IMPORTS INCLZU2024-01-12