FDA.report

Stephens Instruments

Primary DI
00810799039965
Brand
Stephens Instruments
Company
KRISHNA IMPORTS INC
Model
SSD8 1070
Catalog number
SSD8 1070
Device description
Bowman Lacrimal Probe, 00-0, 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

Related Records

Contact Domains

Product Codes

CodeName
HNWDilator, lachrymal

Product Code Classifications

CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810799039965PackageGS110In Commercial Distribution
00810799039972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810799039965008107990399658107990399650810799039965
00810799039972008107990399728107990399720810799039972

GMDN Terms

TermDefinition
Lacrimal probe, single-useA sterile, hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible metal, with a blunt bulbous tip, used for exploring the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods

Method
Ethylene Oxide

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
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 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

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