FDA.reportPublic FDA data

NA

Primary DI
05060797551029
Brand
NA
Company
David Scott Company
Model
BD010
Catalog number
BD010
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.
Published
2022-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060797551026PrimaryGS10
05060797551029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506079755102615060797551026
05060797551029050607975510295060797551029

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
073814568
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060797554232NADSC-800-0049BD1002025-01-10
15060797554263Blue DiamondBD2190BD21902025-01-10
15060797554645NABD-CC-PRBD-CC-PR2025-01-10
15060797554256NABD301BD3012025-01-03
15060797554140Blue DiamondDSC-800-0013DSC-SLPS2024-11-21
15060797554225NABD341BD3252024-11-21
15060797554218NADSC-36363DSC-363632024-11-19
15060797553341NAWSHP0101WSHP01012024-04-23
15060797553358NAWSHP0102WSHP01022024-04-23
15060797553365NAWSHP0102-MWSHP0102-M 2024-04-23
15060797553372NAWSHP0103WSHP0103 2024-04-23
15060797553389NAWSHP0103-MWSHP0103-M2024-04-23
15060797553396NAWSHP-PEWSHP-PE2024-04-23
15060797554294NAWSHP0104-PRWSHP0104-PR2024-04-23
15060797554058NADSC-800-0396DSC-800-03962024-04-17
15060797554188David Scott Company DSC-1009-001DSC-1009-0012024-03-21
15060797553648Blue DiamondBDAB26BDAB262024-03-20
15060797554065NADSC-800-0271DSC-800-02712024-03-20
15060797554133NABD330BD3302024-03-20
15060797554157NABD150BD1502024-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060624123696CS Align Pro Support - Replacement PadsCARE SURGICAL LIMITEDCCX2026-03-23
05060624126970CS Align Pro SupportCARE SURGICAL LIMITEDCCX2026-03-23
00850055249066Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249134Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249141Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249165Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249172Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249189Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249196Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249202Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249219Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249318Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249325Prime Medical LLCPrime Medical LLCCCX2026-03-05
00850055249332Prime Medical LLCPrime Medical LLCCCX2026-03-05
05060624127182CS Easy Prone (170 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127199CS Easy Prone (170 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127342CS FlexiFin™ Stirrup Pads (Pair) – Low BMI Patients CARE SURGICAL LIMITEDCCX2026-01-26
05060624127366CS Easy Prone (150 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127373CS Easy Prone (150 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127397CS Easy Prone (150 mm) - Pelvis Only (Grey) CARE SURGICAL LIMITEDCCX2026-01-26
05060624127403CS Easy Prone (170 mm) - Pelvis only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127458CS Easy Prone (200 mm) - GreyCARE SURGICAL LIMITEDCCX2026-01-26
05060624127465CS Easy Prone (200 mm) - Chest only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
05060624127472CS Easy Prone (200 mm) - Pelvis only (Grey)CARE SURGICAL LIMITEDCCX2026-01-26
00199972000184CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000191CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000207CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
00199972000214CuraplexBOUND TREE MEDICAL, LLCCCX2026-01-23
50749756401352DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-01-22
50749756401376DeRoyalDEROYAL INDUSTRIES, INC.CCX2026-01-22