ALLEN

Basic Information

• Brand Name: ALLEN
• Primary DI: 00615521002176
• Version / Model: 103003
• Catalog Number: A-70100
• Company Name: ALLEN MEDICAL SYSTEMS, INC.
• Labeler DUNS: 147805894
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-26
• Public Version: 1
• Public Version Date: 2023-06-05
• Public Version Status: New
• Public Device Record Key: 60453134-710c-4ed8-8f13-809fc23ab9f7

Device Description

Allen Flex Frame

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37255	Universal operating table top	A component of a modular operating table designed as a detachable table top that can be adjusted to support a patient during many types of surgical interventions. It may consists of many articulated sections that can be elevated or lowered for contouring to accommodate numerous anatomical positions (e.g., the whole table top may be adjusted to form a curved surface), or intended to be used in conjunction with dedicated accessories (i.e., positioners, traction devices) to satisfy the requirements of many clinical specialties; it may have x-ray transparent features.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00615521002176	GS1

Customer Contacts

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