Blue Diamond

Basic Information

• Brand Name: Blue Diamond
• Primary DI: 15060797551095
• Version / Model: BD010-S
• Catalog Number: BD010-S
• Company Name: David Scott Company
• Labeler DUNS: 073814568
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: bdb83bd7-66f9-4981-b6ae-12f55faf3fea

Device Description

Pediatric Stirrups Straps are designed to support small infants to approximately two years in age when in an infant stirrup that has a clip to attach these lloped straps. Assists in placing the patient in lithotomy position when access to the perineum is required. Flexible construction allows for infinite adjustment of position. Disposable loop style straps help avoid cross contamination from patient to patient. Quick set-up. Disposable loop style straps are sold separately (BD010-S). Sold as a case of 10 each.

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
FMP	Protector, Skin Pressure	General Hospital	880.6450	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
Primary	15060797551095	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	2	Inch
Length	10	Inch
Height	.25	Inch