AngelMed Guardian Torque Wrench

Basic Information

• Brand Name: AngelMed Guardian Torque Wrench
• Primary DI: 00850012625018
• Version / Model: 2100-001
• Catalog Number: 2100-001
• Company Name: Angel Medical Systems, Inc.
• Labeler DUNS: 171391779
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-25
• Public Version: 2
• Public Version Date: 2021-08-20
• Public Version Status: Update
• Public Device Record Key: 85de1883-d02c-4d23-9230-ac29d596219c

Device Description

Hex Torque Wrench (Separate, in Sterile Pack)

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QBI	Acute coronary syndrome event detector	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63133	Surgical torque wrench, single-use	A sterile hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850012625018	GS1
Package	10850012625015	GS1	Pack	2	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
P150009	000