BX Series Reusable Biopsy Forceps

Basic Information

• Brand Name: BX Series Reusable Biopsy Forceps
• Primary DI: 00666416130108
• Version / Model: BX210N
• Catalog Number: BX210N
• Company Name: Primed Instruments Inc
• Labeler DUNS: 254491293
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: cde27d74-4bfd-4d43-953e-510e6ec57102

Device Description

Reusable biopsy forceps with serrated jaws and no needle. HIBC/UPN: M453BX210N0

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NON	Forceps, Biopsy, Non-Electric, Reprocessed	Gastroenterology, Urology	876.1075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38810	Flexible endoscopic biopsy forceps, reusable	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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00666416130108	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: 155cm

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. Each device is individually packaged.