FDA.reportPublic FDA data

Devon

Primary DI
10192253053098
Brand
Devon
Company
Cardinal Health 200, LLC
Model
571710
Catalog number
571710
Device description
Light Handle without Hinge
Published
2025-06-09
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
FSYLight, surgical, ceiling mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253053096PrimaryGS10
10192253053098Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225305309650192253053096
1019225305309810192253053098

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment handle cover, single-useA device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
300
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
B510SL700700LED1ADVANCED SURGICAL LAMP ADVANCED INSTRUMENTATIONS, INC.FSY2026-03-24
20192253051985DevonCardinal Health 200, LLCFSY2026-03-11
00850053798016APEX LEDBurton Medical, LLCFSY2026-02-19
00684706009682iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009699iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009705iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009712iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009729iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009736iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009743iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009750iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009767iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009774iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009781iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009798iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009811iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00684706009828iCE Surgical LightAmico Clinical Solutions CorpFSY2026-01-22
00724995243593ALYONSTERIS CORPORATIONFSY2026-01-05
00684706009675iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-25
00684706009644iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009651iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009668iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-24
00684706009330iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009347iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009361iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009378iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009385iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009392iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009408iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15
00684706009415iCE Surgical LightAmico Clinical Solutions CorpFSY2025-07-15