Blue Diamond

FDA UDI

Class I (US FDA UDI)

by David Scott Company.

Identity

Trade Name: Blue Diamond FDA UDI
Generic Name: Leg procedure positioner FDA UDI
Device Name: 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. FDA UDI
Model / Reference: BD010-S FDA UDI
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. FDA UDI

Identifiers

Catalog Number: BD010-S FDA UDI
Primary DI / UDI-DI: 15060797551095 FDA UDI
FDA Product Code: FMP FDA UDI
GMDN Term: Leg procedure positioner FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.6450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 2 Inch FDA UDI
Length — 10 Inch FDA UDI
Height — .25 Inch FDA UDI

Category: Leg procedure positioner

Blue Diamond by David Scott Company. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Leg procedure positioner.

Arthrex® — Arthrex, Inc. · Class I
De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
De Mayo V2E Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
De Mayo V2E Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
Proctology support — Reison Medical AB · Class I
De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
De Mayo D2® Knee Positioner® — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: David Scott Company.

Sources (1)

FDA UDI bdb83bd7-66f9-4981-b6ae-12f55faf3fea 36 fields · synced May 30, 2026