FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50192253053799
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
31143006
Catalog number
31143006
Device description
Devon™ Knee and Body Strap 60" x 4" (2.0 m x 10.2 cm)
Published
2022-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253053799PackageGS16In Commercial Distribution
10192253053791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225305379950192253053799
1019225305379110192253053791

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

Regulatory Flags#

DUNS number
961027315
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260217222176AMTRION Claw 4025Amtrion GmbHFWZ2026-05-26
00696588008257De Mayo Universal Distractor®Innovative Medical Products, IncFWZ2026-01-20
10653405986362CONMEDConmed CorporationFWZ2026-01-17
30653405986373CONMEDConmed CorporationFWZ2026-01-17
20653405990182CONMEDConmed CorporationFWZ2026-01-17
00696588008240De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-12-16
00696588008165De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-09-17
00696588008172De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-09-17
00696588008141De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-08-28
00696588008158De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-08-28
00696588008127De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-08-18
00696588008134De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-08-18
00696588008110De Mayo Universal Distractor®Innovative Medical Products, IncFWZ2025-08-11
00696588008073De Mayo Knee Positioner®Innovative Medical Products, IncFWZ2025-08-05
00696588008080De Mayo Knee Positioner®Innovative Medical Products, IncFWZ2025-08-05
00696588008097De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-07-28
00696588008103De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2025-07-28
00696588008066De Mayo Adapt2Fit® Modular Knee Positioner Innovative Medical Products, IncFWZ2025-06-30
00696588008035Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008042Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008059Exact-Fit® De Mayo Lateral Positioner®Innovative Medical Products, IncFWZ2025-06-04
00696588008028MorphBoard®Innovative Medical Products, IncFWZ2025-05-28
00696588007960MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007977MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007984MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588007991MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588008004MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00696588008011MorphBoard®Innovative Medical Products, IncFWZ2025-05-08
00724995245016ClampSTERIS CORPORATIONFWZ2025-05-05
00696588007922UKnee Suspended Knee PositionerInnovative Medical Products, IncFWZ2025-04-09