ArmGuard™

Basic Information

• Brand Name: ArmGuard™
• Primary DI: 10811836030454
• Version / Model: 40207
• Company Name: Dan Allen Surgical LLC
• Labeler DUNS: 040876183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2021-05-17
• Public Version: 3
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: ac8ae0d7-1f0a-4c6c-b567-32c95ab2ff16

Device Description

ArmGuard XL Width Extender Packs - Each Pack contains: Two Width Extender Pads for table mattresses up to 4 in | 10.2 cm. Case of 12 ea. 00811836030457 (model #40204)

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65157	Operating table mattress extension pad	A cushioned pad intended to increase the surface area of an operating table mattress upon which the patient is placed. It is attached to the operating table (e.g., table rails, patient restraint anchor) and is typically used to extend the mattress width to support a bariatric patient’s arms during a surgical procedure. 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	00811836030457	GS1
Primary	10811836030454	GS1