Spline®

Basic Information

• Brand Name: Spline®
• Primary DI: 00889024011632
• Version / Model: 1230
• Company Name: ZIMMER DENTAL INC.
• Labeler DUNS: 103167086
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2017-02-13
• Public Version: 3
• Public Version Date: 2022-03-10
• Public Version Status: Update
• Public Device Record Key: 8b6bdb23-bc3d-40d3-891d-1bc141b8aaef

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: No
• 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: 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
NHA	ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61640	Dental implant abutment analog, laboratory	A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889024011632	GS1
Unit of Use	00889024487451	GS1

Customer Contacts

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