WaffleGrip PadLock Bracket Set

Basic Information

• Brand Name: WaffleGrip PadLock Bracket Set
• Primary DI: 00850011479643
• Version / Model: A330
• Catalog Number: A330
• Company Name: AUGUSTINE TEMPERATURE MANAGEMENT LLC
• Labeler DUNS: 965879187
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-10
• Public Version: 1
• Public Version Date: 2022-10-18
• Public Version Status: New
• Public Device Record Key: bfb57c91-010b-490c-b54e-0815f46a9374

Device Description

WaffleGrip PadLock Bracket Set for WaffleGrip Trendelenburg Positioning Kit for Warming Pad

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: 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: 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
62789	Operating table non-slip back pad	A non-slip cushioned pad, typically with a pressure-sensitive adhesive, intended to be placed between an operating table mattress and a patient’s back to secure the patient to the table and prevent them from sliding on the table top, typically while placing them in the Trendelenburg position or applying traction pulling forces on the legs during surgery; it may also be intended to aid in distributing patient body weight over a larger surface area and in preventing pressure sores and tissue necrosis on prominent parts of the body during the procedure. Additional securing devices [e.g., straps, adaptors, clamps] may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850011479643	GS1

Customer Contacts

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