SHARD

Basic Information

• Brand Name: SHARD
• Primary DI: 00814639025422
• Version / Model: N-TW2713
• Catalog Number: N-TW2713
• Company Name: APPLIED DENTAL, INC.
• Labeler DUNS: 017524666
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-31
• Public Version: 1
• Public Version Date: 2022-06-08
• Public Version Status: New
• Public Device Record Key: a2b250c4-76dd-4768-8991-b6d0a6a27c84

Device Description

SHARD Hypodermic Needles 27G*13mm (1/2") Thin wall.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MEG	Syringe, Antistick	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16627	Medication transfer needle, non-filtering/non-vented	A slender, rigid, sharp or blunt metal tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It consists of a short needle sufficient to penetrate the vial stopper and extract all the medication. It is typically of 20 gauge to provide a high-flow rate with minimum coring. It does not include a filter or a back-pressure venting feature. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814639025422	GS1
Package	10814639025429	GS1	box	100	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072739	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 40 Degrees Celsius