GripMate™

Basic Information

• Brand Name: GripMate™
• Primary DI: 00370095000002
• Version / Model: GripMate™
• Catalog Number: GripMate™
• Company Name: SUN PHARMACEUTICAL INDUSTRIES, INC.
• Labeler DUNS: 079491524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-12
• Public Version: 1
• Public Version Date: 2025-05-20
• Public Version Status: New
• Public Device Record Key: b5c655e7-4b70-4843-a45e-28a028fe29b2

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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZH	Introducer, Syringe Needle	General Hospital	880.6920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62117	Syringe-loaded medication/vaccine injector, manual, home-use	A hand-held, manually-powered, mechanical device intended to be used in conjunction with an appropriate plunger syringe and needle for the self-administration of a medication or vaccine to a patient intramuscularly (IM) and/or subcutaneously; it is not intended for intradermal injection. It is typically a spring-loaded mechanical assembly intended to accept a prefilled syringe and needle; the syringe, needle and pharmaceutical are not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00370095000002	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 28 Degrees Celsius