Park Dental Research Corp

Basic Information

• Brand Name: Park Dental Research Corp
• Primary DI: D769OR125
• Version / Model: OR-125
• Company Name: PARK DENTAL RESEARCH CORP
• Labeler DUNS: 011441508
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2015-11-09
• Public Version: 3
• Public Version Date: 2018-10-22
• Public Version Status: Update
• Public Device Record Key: 87d0672e-a076-401c-bbcb-ecdce1c88ea9

Device Description

O-Ring Large (25 pack)

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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44806	Surgical instrument seal/seal maintenance set	A seal/collection of seals (e.g., O-rings, shaped or viscous gaskets) intended to be used to replace a damaged sealing component in the maintenance of certain endoscopes, microscopes, injectors, or other surgical instruments. It may include supportive hand tools (screwdrivers). It is not a laparoscopic access cannula seal.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D769OR125	HIBCC
Unit of Use	H7000325	HIBCC

Customer Contacts

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