Gripper™ Soft Copper Band

Basic Information

• Brand Name: Gripper™ Soft Copper Band
• Primary DI: 10810000527486
• Version / Model: S702-17
• Catalog Number: S702-17
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-07-26
• Public Version: 4
• Public Version Date: 2023-12-27
• Public Version Status: Update
• Public Device Record Key: 70234776-2fbd-4fd4-ae19-d4a3d6db9ac9
• Distribution End Date: 2022-08-25

Device Description

Size 17 Gripper™ Soft Copper Band Refill (Pkg. of 10 pcs.)

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: 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: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCQ	Tube Impression And Matrix	Dental	872.6570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38786	Dental matrix band, single-use	A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810000527486	GS1
Unit of Use	00810000527489	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	11.05	Millimeter
Height	12.10	Millimeter