R-11 Standard Packing Instrument Serrated

Basic Information

• Brand Name: R-11 Standard Packing Instrument Serrated
• Primary DI: 00310866000657
• Version / Model: 26110
• Catalog Number: 26110
• Company Name: PASCAL COMPANY, INC.
• Labeler DUNS: 009260217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-31
• Public Version: 2
• Public Version Date: 2023-06-30
• Public Version Status: Update
• Public Device Record Key: 9351351b-ad4d-4f1f-af17-c22785602755

Device Description

Retraction Cord Packing Instrument standard with serrated tip

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["High-level Disinfectant", "Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIF	Accessories, Retractor, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64164	Gingival retraction cord packing tool	A hand-held manual dental instrument designed specifically to pack a gingival retraction cord between the tooth and the gingiva during abutment preparation. It is a metallic single- or double-ended device with a spatula-like tip(s) which may have serrated edges. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00310866000657	GS1

Customer Contacts

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