CROC Series Endoscopic Device

Basic Information

• Brand Name: CROC Series Endoscopic Device
• Primary DI: 40666416140136
• Version / Model: RC924
• Catalog Number: RC924
• Company Name: Primed Instruments Inc
• Labeler DUNS: 254491293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 80
• Record Status: Published
• Publish Date: 2017-10-23
• Public Version: 4
• Public Version Date: 2019-08-21
• Public Version Status: Update
• Public Device Record Key: 6cb88bf4-44ae-429f-b2cb-23dd53c11956

Device Description

Single-use wide angled retrieval device with rat tooth/alligator hybrid jaws and ezSlide® sheath. HIBC/UPN: M453RC9244

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: Yes
• 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
FCL	Forceps, Biopsy, Non-Electric	Gastroenterology, Urology	876.1075	1

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
Primary	40666416140136	GS1
Unit of Use	00666416140138	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Required Working Channel: 2.8mm
Device Size Text, specify			Jaw Diameter: 2.4mm
Device Size Text, specify			Working Length: 230cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Instruments should be stored in the sterile package at room temperature in a clean and dry area away from direct sunlight. Each case contains 16 dispenser boxes. Each dispenser box contains 5 devices.