FDA.reportPublic FDA data

CS FlexiFinless™ Stirrup - Left

Primary DI
05060624126468
Brand
CS FlexiFinless™ Stirrup - Left
Company
CARE SURGICAL LLC
Model
CSM3051
Catalog number
CSM3051
Published
2026-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EYDStirrups

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYDStirrupsGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060624126468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060624126468050606241264685060624126468

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient positioning set, reusableA collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent a patient from sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: a base plate/bar that serves as a foundation to which patient positioners are attached, clamps/adaptors, and disposable/reusable padded positioners dedicated to a body part (e.g., non-slip positioning pad, headrest). This is a reusable device.

Regulatory Flags#

DUNS number
117436534
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060624126444CS FlexiFinless™ Stirrups (Pair) CSM3050CSM30502026-03-25
05060624126475CS FlexiFinless™ Stirrup - RightCSM3052CSM30522026-03-25
05060624127168CS FlexiFinless™ Stirrup Pads - Hook and Loop (Pair)CSM3059CSM30592026-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060624126444CS FlexiFinless™ Stirrups (Pair) CARE SURGICAL LLCEYD2026-03-25
05060624126475CS FlexiFinless™ Stirrup - RightCARE SURGICAL LLCEYD2026-03-25
05060624125904CS FlexiFin™ Stirrups - Hook & Loop - Left (Stirrup Only)CARE SURGICAL LIMITEDEYD2025-03-28
05060624125911CS FlexiFin™ Stirrups - Hook & Loop - Right (Stirrup Only)CARE SURGICAL LIMITEDEYD2025-03-28
05060624125928CS FlexiFin™ Max Stirrups - Hook & Loop - Left (Stirrup Only)CARE SURGICAL LIMITEDEYD2025-03-28
05060624125935CS FlexiFin™ Max Stirrups - Hook & Loop - Right (Stirrup Only)CARE SURGICAL LIMITEDEYD2025-03-28
05060624127540CS FlexiFin™ Stirrups (Pair) CARE SURGICAL LIMITEDEYD2025-03-28
05060624127557CS FlexiFin™ Stirrups - Hook & Loop (Pair)CARE SURGICAL LIMITEDEYD2025-03-28
05060624127564CS FlexiFin™ Max Stirrups - Hook & Loop (Pair)CARE SURGICAL LIMITEDEYD2025-03-28
05060624129131CS FlexiFin™ Max Stirrups (Pair)CARE SURGICAL LIMITEDEYD2025-03-28
05060624129568CS FlexiFin™ Stirrup - Left (Stirrup Only)CARE SURGICAL LIMITEDEYD2025-03-28
05060624129575CS FlexiFin™ Stirrup - Right (Stirrup Only)CARE SURGICAL LIMITEDEYD2025-03-28
05060624129582CS FlexiFin™ Max Stirrup - Left (Stirrup Only)CARE SURGICAL LIMITEDEYD2025-03-28
05060624129599CS FlexiFin™ Max Stirrup - Right (Stirrup Only)CARE SURGICAL LIMITEDEYD2025-03-28
00724995217198NASTERIS CORPORATIONEYD2022-12-20
00724995217204NASTERIS CORPORATIONEYD2022-12-20
00724995217228NASTERIS CORPORATIONEYD2022-12-20
00724995217266NASTERIS CORPORATIONEYD2022-12-20
00724995217273NASTERIS CORPORATIONEYD2022-12-20
00724995217259NASTERIS CORPORATIONEYD2022-12-20
00724995217280NASTERIS CORPORATIONEYD2022-12-20
00724995217297NASTERIS CORPORATIONEYD2022-12-20
00724995217303NASTERIS CORPORATIONEYD2022-12-20
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00815235023751UMF MedicalUNITED METAL FABRICATORS, INC.EYD2018-09-25
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