NA

Basic Information

• Brand Name: NA
• Primary DI: 15060797551026
• Version / Model: BD010
• Catalog Number: BD010
• Company Name: David Scott Company
• Labeler DUNS: 073814568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2022-07-07
• Public Version: 1
• Public Version Date: 2022-07-15
• Public Version Status: New
• Public Device Record Key: 1922f67a-c08f-422a-9cb0-69f04ac76181

Device Description

Flexible Infant - Pediatric Stirrups are firm, yet gentle. Used with small infants approximately two years in age. Assists in placing the patient in lithotomy position when access to the perineum is required. Flexible construction allows for infinite adjustment of position. Over-extension is easily avoided, even after draping. Disposable loop style straps help avoid cross contamination from patient to patient. Built-in rail clamps provide quick set-up. Disposable loop style straps are sold separately (BD010-S). Sold as a Pair.

Device Characteristics

• Single Use: No
• 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: No
• 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
55836	Leg procedure positioner	A preformed device (e.g., holder, sling, cushion, foam pad, wedge, multi-jointed structure) designed to be attached to an operating table to stabilize a patient's leg (e.g., thigh, knee, ankle) for adequate positioning and support of the body part during a medical/surgical procedure (e.g., orthopaedic surgery, examination, office procedure). It is typically padded to avoid damage of the skin/muscles/nerves, and components for attachment to the operating/examination table are typically included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	05060797551029	GS1
Primary	15060797551026	GS1

Customer Contacts

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