AESCULAP

Basic Information

• Brand Name: AESCULAP
• Primary DI: 04046955075768
• Version / Model: MB595R
• Catalog Number: MB595R
• Company Name: AESCULAP, INC.
• Labeler DUNS: 082594540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-08
• Public Version: 2
• Public Version Date: 2023-02-27
• Public Version Status: Update
• Public Device Record Key: eeb1462b-0ca9-45a1-a3d3-bac782421473
• Distribution End Date: 2023-02-23

Device Description

MC IVOR Ring Retractor, blade, right, Fig. 2, depth: 23 mm, width: 57 mm, non-sterile, reusable

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KBN	GAG, MOUTH	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35085	Mouth gag, adjustable, reusable	A mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046955075768	GS1

Customer Contacts

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