Needle Adapter

Basic Information

• Brand Name: Needle Adapter
• Primary DI: 00609960001272
• Version / Model: ADAPT/DNTL
• Catalog Number: ADAPT/DNTL
• Company Name: DERMATOLOGIC LAB AND SUPPLY, INC.
• Labeler DUNS: 021628771
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-10
• Public Version: 2
• Public Version Date: 2018-08-29
• Public Version Status: Update
• Public Device Record Key: d4dda2f0-392f-4eef-95f0-3e861c981134

Device Description

ADAPTER, FOR DENTAL NEEDLE, 3/32in X 1 1/8in LONG SHAFT

Device Characteristics

• Single Use: No
• 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: No
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62395	Electrosurgical electrode extension	A long, thin electrical conductor intended to extend the length of a monopolar electrosurgical electrode during an open surgical procedure. The electrode is fixed to the distal end of the device and the proximal end is attached to an electrosurgical handpiece. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00609960001272	GS1

Premarket Submissions

Submission Number	Supplement Number
K001029	000