Orbit-Snare

Basic Information

• Brand Name: Orbit-Snare
• Primary DI: 04052838015448
• Version / Model: 02-25-230
• Catalog Number: 02-25-230
• Company Name: Medi-Globe GmbH
• Labeler DUNS: 318130267
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 157871a4-a598-4b5e-8469-464b998f289a

Device Description

Orbit-Snare, Rotatable Polypectomy Snare Hexagonal, Loop Diameter 25 mm, Catheter Diameter 2.5 mm, Sheath Length 230 cm

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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDI	Snare, Flexible	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35622	Flexible polypectomy snare, single-use	A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current. It typically consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	4052838015455	GS1	Box	10	In Commercial Distribution
Primary	04052838015448	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and avoid exposure to sunlight and chemical fumes
• Type: Storage Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius