Tech Medical Services

Basic Information

• Brand Name: Tech Medical Services
• Primary DI: 00851695005012
• Version / Model: PS6000
• Company Name: TECHMEDICAL SERVICES, INC.
• Labeler DUNS: 556093219
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: 48addd89-19a4-4e20-aeef-f7362fa67518

Device Description

Wired Gamma Probe Cover

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKX	Drape, Surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65056	Intraoperative gamma radiation detection system probe cover	A polymer sheath designed to cover an intraoperative gamma radiation detection system probe (not included) to create a physical barrier between the patient and the probe. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851695005012	GS1
Package	10851695005019	GS1	Inner	10	In Commercial Distribution