FDA.reportPublic FDA data

NA

Primary DI
03596010578136
Brand
NA
Company
Smith & Nephew, Inc.
Model
72200635
Catalog number
72200635
Device description
BOOT INSERT PAD
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQZCOMPONENT, TRACTION, NON-INVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQZComponent, Traction, Non-InvasiveOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
23596010578130PackageGS12In Commercial Distribution
03596010578136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2359601057813023596010578130
03596010578136035960105781363596010578136

GMDN Terms#

Term, Definition table
TermDefinition
Traction bootAn orthopaedic device designed as an open boot that is attached and tightly secured with laces or straps to the foot or both feet of the patient so that traction can be applied to the patient's body. It is typically used during an orthopaedic surgical trauma intervention when traction is being applied to a patient's leg or legs when broken leg bones are being drawn apart, repositioned, and set to the correct position, or in conjunction with a traction table for the application of traction to the patient's spine. It is available in various foot sizes and has a solid sole construction that can be securely attached/locked to other components of the table. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423797MillenniumAvalign Technologies, Inc.KQZ2026-08-07
00810075281675BoneFoamBONE FOAM, INC.KQZ2026-07-28
00810075281668BoneFoamBONE FOAM, INC.KQZ2026-06-12
00844107000804QuikBow Arbutus Medical IncKQZ2026-04-28
00848340016806ALLENHILL-ROM, INC.KQZ2026-04-24
00888867484986Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485099Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485105Arthrex®ARTHREX, INC.KQZ2025-12-10
00888867485112Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867484983Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485096Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485102Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485119Arthrex®ARTHREX, INC.KQZ2025-12-10
00810075281521BoneFoamBONE FOAM, INC.KQZ2025-08-15
00810075281491BoneFoamBONE FOAM, INC.KQZ2025-08-15
00810075281514BoneFoamBONE FOAM, INC.KQZ2025-08-15
00888867502710Arthrex®ARTHREX, INC.KQZ2025-08-14
10888867502717Arthrex®ARTHREX, INC.KQZ2025-08-14
20845854082925Paradigm RevolutionConmed CorporationKQZ2023-06-13
20845854082932Paradigm RevolutionConmed CorporationKQZ2023-06-13
0078755101165490403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
00787551011678NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
2078755101165890403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
20787551011672NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
00816342020718Accessories, arthroscopicPARCUS MEDICAL LLCKQZ2022-12-06
00842331141027Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331143373Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-11
00842331136627Novo Surgical Inc. NOVO SURGICAL, INC.KQZ2022-11-10
00610570001712"100 FT. 3/16"" TRACTION CORD"Bird & Cronin, LLCKQZ2022-08-20
00610570001750"1500 FT. 3/16"" TRACTION CORD"Bird & Cronin, LLCKQZ2022-08-20