AESCULAP

Basic Information

• Brand Name: AESCULAP
• Primary DI: 04038653316205
• Version / Model: EJ996
• Catalog Number: EJ996
• Company Name: Aesculap AG
• Labeler DUNS: 315018218
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2020-06-17
• Public Version: 2
• Public Version Date: 2020-07-01
• Public Version Status: Update
• Public Device Record Key: 9ed31a74-f2f2-4c22-88d7-491c54181d98

Device Description

INSUFFL.NEEDLE D:2.1/150MM STERILE

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIF	Insufflator, laparoscopic	Obstetrics/Gynecology	884.1730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12750	Spring-loaded pneumoperitoneum needle, single-use	A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04038653342549	GS1
Primary	04038653316205	GS1

Customer Contacts

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