NA

Basic Information

• Brand Name: NA
• Primary DI: 00889024035546
• Version / Model: 1191-48
• Catalog Number: 00-1191-048-00
• Company Name: Zimmer, Inc.
• Labeler DUNS: 056038268
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2017-09-26
• Public Version: 6
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: d4ee076d-6b0d-43f8-930c-025e0b4a4784
• Distribution End Date: 2023-02-01

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: 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
JDQ	CERCLAGE, FIXATION	Orthopedic	888.3010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66933	Orthopaedic bone cerclage wire	An implantable thin metallic cord intended to be tightened with a knot to form a loop or ring around a fractured orthopaedic bone and/or stabilize an implant (typically a fixation plate) for treatment. It is not rigid (i.e., not a pin/K-wire) and not intended to be used in spinal bones. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889024035546	GS1
Unit of Use	70889024035545	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150889	000

Device Sizes

Type	Value	Unit	Text
Length	24	Inch
Device Size Text, specify			USP Size 10, Metric Size 12, B&S 16 Ga., 0.048 Inch, Diameter