AIM

Basic Information

• Brand Name: AIM
• Primary DI: B508EA21007
• Version / Model: A2-1007
• Company Name: ADVANCED INSTRUMENTATION FOR MEDICINE,INC.
• Labeler DUNS: 080478537
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-30
• Public Version: 3
• Public Version Date: 2019-03-08
• Public Version Status: Update
• Public Device Record Key: b8489ccd-1d57-449a-8e80-09b985d96688
• Distribution End Date: 2018-06-20

Device Description

AIM HOOK SCISSOR 45CM 5MM MONOPOLAR

Device Characteristics

• Single Use: No
• 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: No
• 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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32617	Laparoscope system, reusable	An assembly of laparoscopes and their accessories used for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). The insertion is typically through an incision(s) made in the abdominal wall (routinely just below the umbilicus or in the near vicinity). This system is mostly used for gynaecological procedures involving the evaluation/treatment of abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, or for female sterilization. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B508EA21007	HIBCC