FDA.reportPublic FDA data

Body Armor® Stirrup Walker

Primary DI
00609271040069
Brand
Body Armor® Stirrup Walker
Company
DARCO INTERNATIONAL, INC.
Model
BSS1W
Catalog number
BSS1W
Device description
Short, white (small)
Published
2023-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NOCSplint, extremity, non-inflatable, external, non-sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOCSplint, Extremity, Non-Inflatable, External, Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609271040066PackageGS14In Commercial Distribution
20609271040063PackageGS112In Commercial Distribution
00609271040069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927104006610609271040066
2060927104006320609271040063
00609271040069006092710400696092710400690609271040069

GMDN Terms#

Term, Definition table
TermDefinition
Ankle/foot orthosisA prefabricated (non-customized) externally applied and wearable appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include patient adaptable plantar inserts. This is a reusable device.

Regulatory Flags#

DUNS number
184231298
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
00609271999336Aircore™ InsoleACI02026-07-20
00609271999343Aircore™ InsoleACI12026-07-20
00609271999374Aircore™ InsoleACI42026-07-20
00609271999381Aircore™ InsoleACI52026-07-20
00609271999473Aircore™ InsoleACI22026-07-20
00609271999480Aircore™ InsoleACI32026-07-20
0060927120013516'' DLX POST-OP KNEE IMMOB462-0012-30462-0012-302023-02-08
0060927120015916'' DLX POST-OP KNEE IMMOB462-0012-40462-0012-402023-02-08
0060927120017316'' DLX POST-OP KNEE IMMOB462-0012-50462-0012-502023-02-08
0060927120018016'' DLX POST-OP KNEE IMMOB462-0012-60462-0012-602023-02-08
0060927120019716'' DLX POST-OP KNEE IMMOB462-0012-70462-0012-702023-02-08
0060927120033320'' DLX POST-OP KNEE IMMOB462-0014-30462-0014-302023-02-08
0060927120035720'' DLX POST-OP KNEE IMMOB462-0014-40462-0014-402023-02-08
0060927120037120'' DLX POST-OP KNEE IMMOB462-0014-50462-0014-502023-02-08
0060927120038820'' DLX POST-OP KNEE IMMOB462-0014-60462-0014-602023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOB462-0014-70462-0014-702023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOB462-0025-10462-0025-102023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOB462-0026-10462-0026-102023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOB462-0028-10462-0028-102023-02-08
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"E59410E594102023-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810003753694KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753717KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753731KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753755KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753854KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753878KENAFLEXX KENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753892KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753915KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753533KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753557KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753571KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753595KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753618KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753632KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753656KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753670KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753779KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753793KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753816KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753830KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00609271040021Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040038Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040045Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040229Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040236Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040243Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-11-02
00609271040007Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22
00609271040014Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22
00609271040052Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22
00609271040076Body Armor® Stirrup WalkerDARCO INTERNATIONAL, INC.NOC2023-09-22