Safehand

Basic Information

• Brand Name: Safehand
• Primary DI: 00810998039629
• Version / Model: EM-PFNGXL-N
• Company Name: Winsight International Solutions, Inc.
• Labeler DUNS: 079694430
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2022-12-13
• Public Version: 2
• Public Version Date: 2023-12-25
• Public Version Status: Update
• Public Device Record Key: 63896caf-4626-4eb5-8d90-501f11850565
• Distribution End Date: 2025-12-13

Device Description

EM-PFNGL SAFEHAND glove NITRILE EXTRA LARGE BLACK PWD FR, 3.5MIL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
NJG	Flasher, Afterimage, Ophthalmic	Ophthalmic	886.1300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61938	Surgical/examination garment kit	A collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00810998039636	GS1
Primary	00810998039629	GS1

Customer Contacts

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