CROC Series Endoscopic Device

Basic Information

• Brand Name: CROC Series Endoscopic Device
• Primary DI: 40666416140112
• Version / Model: H928N
• Catalog Number: H928N
• Company Name: Primed Instruments Inc
• Labeler DUNS: 254491293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 160
• Record Status: Published
• Publish Date: 2017-10-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 923efaa4-7576-497a-89d6-0190a3c4a51c

Device Description

High capacity single-use biopsy forceps with serrated jaws, ezSlide® sheath and no needle. HIBC/UPN: M453H928N3

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
38711	Flexible endoscopic biopsy forceps, single-use	A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	40666416140112	GS1
Unit of Use	00666416140114	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Required Working Channel: 3.2mm
Device Size Text, specify			Jaw Diameter: 2.8mm
Device Size Text, specify			Working Length: 230cm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Biopsy forceps should be stored in the sterile package at room temperature in a clean and dry area away from direct sunlight. Case contains 8 dispenser boxes. Each dispenser box contains 20 devices.