Raptor

Basic Information

• Brand Name: Raptor
• Primary DI: 00816765012567
• Version / Model: 00711178
• Catalog Number: 00711178
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 6
• Public Version Date: 2020-03-17
• Public Version Status: Update
• Public Device Record Key: c08db5f8-17ab-4ce3-b820-6586e32cbbb7
• Distribution End Date: 2020-03-17

Device Description

The disposable Raptor grasping device-mini is be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.

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: Yes
• 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: Yes
• 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
OCZ	Endoscopic grasping/cutting instrument, non-powered	Gastroenterology, Urology	876.1500	2
PTS	Endoscopic grasping/cutting instrument, non-powered, exempt	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33199	Flexible endoscopic tissue manipulation forceps, single-use	A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816765012564	GS1	Box	5	Not in Commercial Distribution	2020-03-17
Primary	00816765012567	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.9	Millimeter
Length	200	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius