Stephens Instruments

Basic Information

• Brand Name: Stephens Instruments
• Primary DI: 00810799039439
• Version / Model: SSD4 1236
• Catalog Number: SSD4 1236
• 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: 4
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 2f3ac5a7-9d33-4701-a6e8-8050b32e9480

Device Description

Josephberg-Besser Scleral Depressor, 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
HNX	Depressor, orbital	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64317	Orbital depressor, single-use	A hand-held ophthalmic surgical instrument designed for extra-orbital displacement of the sclera to facilitate examination/treatment of the surrounding area in the orbital cavity during eye surgery; it may be designed to be used with a light source (not included). Sometimes referred to as a scleral depressor, it is often a double-ended device of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working end(s) slightly angled to improve organ/tissue manipulation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00810799039422	GS1	box	10	In Commercial Distribution
Primary	00810799039439	GS1

Customer Contacts

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

Storage Conditions

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