G/L .070 ESI Male

Basic Information

• Brand Name: G/L .070 ESI Male
• Primary DI: 00841549100611
• Version / Model: 802803
• Company Name: STERNGOLD DENTAL LLC
• Labeler DUNS: 124763728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-02
• Public Version: 2
• Public Version Date: 2023-03-24
• Public Version Status: Update
• Public Device Record Key: d4398833-a263-476a-98fe-ba979f1c9bb9

Device Description

Intracoronal precision slide attachment

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: Yes
• Has Manufacturing Date: Yes
• 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
EGG	Attachment, Precision, All	Dental	872.3165	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38580	Sliding dental precision attachment	A device designed used for the fixation of a dental prosthesis where the male part slides into a precision groove in the female part.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841549100611	GS1

Customer Contacts

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