N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10381780044697
• Version / Model: 119651ND
• Catalog Number: 119651ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-16
• Public Version: 3
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: 4379af7d-b50c-4e8b-a23a-16614552aa54
• Distribution End Date: 2027-12-31

Device Description

GENERAL INSTRUMENT Large Integra distraction Forceps 21cm Closed Arms

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
HTD	FORCEPS	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44378	Bone distraction forceps	A hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780044697	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged