Doctor Nice

Basic Information

• Brand Name: Doctor Nice
• Primary DI: 08964003163648
• Version / Model: 113990
• Company Name: B. Ali Impex
• Labeler DUNS: 645802117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-29
• Public Version: 1
• Public Version Date: 2024-02-06
• Public Version Status: New
• Public Device Record Key: 28e1c291-3301-4cdf-bf5d-cbeaf7b1e59f

Device Description

Spring Bo Divider 4.5 Radius - Bone Caliper 1pk

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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: ["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KTZ	Caliper	Orthopedic	888.4150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35700	Facebow	A caliper-like dynamic dental instrument intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08964003163648	GS1