ZERO-P NATURAL

Basic Information

• Brand Name: ZERO-P NATURAL
• Primary DI: 10705034816418
• Version / Model: 03.617.014S
• Catalog Number: 03617014S
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-30
• Public Version: 4
• Public Version Date: 2022-04-27
• Public Version Status: Update
• Public Device Record Key: 17ec3c37-8bb2-4065-a6e5-3f2f2e31a1d4

Device Description

ZERO-P NATURAL ASSEMBLY TOOL STERILE

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: No
• 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: No
• 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
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY	Orthopedic	888.3060	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61211	Manual orthopaedic bender, single-use	A sterile, manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H98103617014S0	HIBCC
Primary	10705034816418	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K152239	000