FDA.reportPublic FDA data

Blue Diamond

Primary DI
15060797551095
Brand
Blue Diamond
Company
David Scott Company
Model
BD010-S
Catalog number
BD010-S
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.
Published
2022-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060797551095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506079755109515060797551095

GMDN Terms#

Term, Definition table
TermDefinition
Leg procedure positionerA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.25Inch
Length10Inch
Width2Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
508-875-3333customerservice@davidscottco.com

Regulatory Flags#

DUNS number
073814568
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060797551026NABD010BD0102022-07-07
15060797554232NADSC-800-0049BD1002025-01-10
15060797554645NABD-CC-PRBD-CC-PR2025-01-10
15060797554256NABD301BD3012025-01-03
15060797554140Blue DiamondDSC-800-0013DSC-SLPS2024-11-21
15060797554225NABD341BD3252024-11-21
15060797554133NABD330BD3302024-03-20
15060797554157NABD150BD1502024-03-20
15060797554034NABD311BD3252024-03-13
15060797554027NABD325BD3252024-01-17
15060797554119Blue DiamondBD170BD1702023-11-08
15060797554003David Scott CompanyDSC-610DSC-6102023-10-18
15060797554010David Scott CompanyDSC-611DSC-6112023-10-18
15060797554102David Scott CompanyBD2502023-10-16
15060797553839NABD100BD1002023-07-26
15060797553891NADSC-SLPSaDSC-SLPSa2023-07-26
15060797553945NADSC-800-0161DSC-800-01612023-07-26
15060797553136Blue DiamondDSC-SLPS-foam-12DSC-SLPS-foam-122022-07-18
15060797553150NADSC-TKS-PADDSC-TKS-PAD2022-07-18
15060797553167NADSC-TKS-RDSC-TKS-R2022-07-18

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