OSSEOUS Stapes Prosthesis Crimping Forceps

Basic Information

• Brand Name: OSSEOUS Stapes Prosthesis Crimping Forceps
• Primary DI: 08906039316032
• Version / Model: EI04
• Company Name: EON MEDITECH PRIVATE LIMITED
• Labeler DUNS: 930270428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-04
• Public Version: 1
• Public Version Date: 2024-07-12
• Public Version Status: New
• Public Device Record Key: 956e1e66-e534-45cf-9999-9a5c1ab2e9f6

Device Description

It is used to crimping of stapes piston loop after proper placement of stapes piston on long process of incus.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KAE	Forceps, Ent	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11791	Dressing/utility forceps, scissors-like, reusable	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08906039318050	GS1	Laminated Box	1	In Commercial Distribution
Primary	08906039316032	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius