Colorectal Air Syringe-OP EX

Basic Information

• Brand Name: Colorectal Air Syringe-OP EX
• Primary DI: 00860002701318
• Version / Model: ALT-30EX
• Catalog Number: ALT-30EX
• Company Name: TOOLS FOR SURGERY, LLC
• Labeler DUNS: 841842441
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-17
• Public Version: 2
• Public Version Date: 2023-06-13
• Public Version Status: Update
• Public Device Record Key: 5271c269-2dba-4dd6-ae76-7d239526e9ea

Device Description

Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes 3 extender tips.

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: Yes
• 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
FCY	Bulb, Inflation, For Endoscope	Gastroenterology, Urology	876.1500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35800	Endoscope inflation bulb	A device that is used in conjunction with an endoscope and its direct application and which assists in the use of the endoscope. It is a dedicated device shaped as a rubber bulb which is used to feed air via the endoscope to obtain an endoscopic view of the site. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860002701318	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	8.5	Inch