Stephens Instruments

Basic Information

• Brand Name: Stephens Instruments
• Primary DI: 00810799039972
• Version / Model: SSD8 1070
• Catalog Number: SSD8 1070
• Company Name: KRISHNA IMPORTS INC
• Labeler DUNS: 081853285
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 3
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 2aa295c6-b89c-4e30-8cfe-b3a764b2d942

Device Description

Bowman Lacrimal Probe, 00-0, Single use, 10/Box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNW	Dilator, lachrymal	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44359	Ophthalmic surgical probe, single-use	A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810799039965	GS1	box	10	In Commercial Distribution
Primary	00810799039972	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature