AESCULAP

Basic Information

• Brand Name: AESCULAP
• Primary DI: 04038653163687
• Version / Model: FF385R
• Catalog Number: FF385R
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-19
• Public Version: 8
• Public Version Date: 2021-11-29
• Public Version Status: Update
• Public Device Record Key: d3ddb006-84e1-4936-baad-8426336c6b3a

Device Description

MINOP Micro scissors, complete instrument, w/o HF connection, straight, working length: 10 1/2", (265 mm), diam. 2 mm, serrated (oneblade), sharp/sharp, with tubular shaft, rotatable, ring handle, double action, consisting of FF432R, FF433R, FF435R, detachable, non-sterile, reusable, to be used with: FF399R

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: Yes
• PM Exempt: No
• 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
GWG	ENDOSCOPE, NEUROLOGICAL	Neurology	882.1480	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46421	Rigid endoscopic scissors, reusable	A hand-held rigid device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of stainless steel and is designed as a long pair of parallel sliding arms whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a ringed handle at the proximal end. It is typically introduced into the body cavity through the working channel of the endoscope. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04038653163687	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Working length (mm) : 265.000 MM
Device Size Text, specify			Diameter (mm) : 2.000 MM