FDA.reportPublic FDA data

NA

Primary DI
03596010252814
Brand
NA
Company
Smith & Nephew, Inc.
Model
7207023
Catalog number
7207023
Device description
DSTRCTR ANKLE GUHL NON-INVSV.
Published
2015-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
03596010252814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010252814035960102528143596010252814

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888867484983Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485096Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485102Arthrex®ARTHREX, INC.KQZ2025-12-10
10888867485119Arthrex®ARTHREX, INC.KQZ2025-12-10
00810075281514BoneFoamBONE FOAM, INC.KQZ2025-08-15
10888867502717Arthrex®ARTHREX, INC.KQZ2025-08-14
20845854082925ParadigmConmed CorporationKQZ2023-06-13
20845854082932ParadigmConmed CorporationKQZ2023-06-13
2078755101165890403 Shoulder Arthroscopy KitXODUS MEDICAL, INC.KQZ2022-12-08
20787551011672NS90403 Shoulder Suspension KitXODUS MEDICAL, INC.KQZ2022-12-08
00816342020718Parcus InstrumentationPARCUS 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
00610570001712100 FT. 3/16" TRACTION CORDBird & Cronin, LLCKQZ2022-08-20
006105700017501500 FT. 3/16" TRACTION CORDBird & Cronin, LLCKQZ2022-08-20
00610570006588BUCKS BOOT XSBird & Cronin, LLCKQZ2022-08-20
00610570006595BUCKS BOOT SMBird & Cronin, LLCKQZ2022-08-20
00610570006601BUCKS BOOT MDBird & Cronin, LLCKQZ2022-08-20
00610570006618BUCKS BOOT LGBird & Cronin, LLCKQZ2022-08-20
00610570006649BUCKS BOOT UNIV CLSD-COMPLETEBird & Cronin, LLCKQZ2022-08-20
00610570006656DISPOSABLE PAD-UNIVERSAL BOOTBird & Cronin, LLCKQZ2022-08-20
00610570006663SADDLE FOR UNIV BUCKS TRACTIONBird & Cronin, LLCKQZ2022-08-20
00610570011810DISKARD HEAD HALTERBird & Cronin, LLCKQZ2022-08-20
00610570011858DELUXE HEAD HALTER UNIV BLACKBird & Cronin, LLCKQZ2022-08-20
00610570012503SPREADER BAR 12" NOTCHEDBird & Cronin, LLCKQZ2022-08-20
0061057001260220# WATER WEIGHT BAGBird & Cronin, LLCKQZ2022-08-20
00610570068951EXERCISE BAND ANCHOR STRAPS 10/PKBird & Cronin, LLCKQZ2022-08-20
07290015711302D.B.S. Dynamic Brace SystemMEDITRAC LTD.KQZ2022-07-25
00810075280784Bone FoamBONE FOAM, INC.KQZ2022-05-22