Handle

Basic Information

• Brand Name: Handle
• Primary DI: 00841439104194
• Version / Model: MTGBSUB1
• Catalog Number: MTGBSUB1
• Company Name: MEDTEC, INC.
• Labeler DUNS: 103977526
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-02
• Public Version: 6
• Public Version Date: 2020-03-19
• Public Version Status: Update
• Public Device Record Key: 4162e08a-264c-48bf-be6c-2e3e417d25e2

Device Description

Arm up T-grip positioner

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IXQ	Table, radiographic, stationary top	Radiology	892.1980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40900	Radiological arm/leg positioner	A device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841439104194	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K973842	000

Device Sizes

Type	Value	Unit	Text
Length	13.2	Inch
Width	8.7	Inch