FDA.reportPublic FDA data

Custom Healthcare Systems of Virginia

Primary DI
20811870035658
Brand
Custom Healthcare Systems of Virginia
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
L1000-19706
Published
2021-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LROGeneral Surgery Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870035658PackageGS15In Commercial Distribution
00811870035654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003565820811870035658
00811870035654008118700356548118700356540811870035654

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
175254820
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
20811870035757Custom Healthcare Systems of VA, LLCCPT56102021-08-11
20811870035962Custom Healthcare Systems of VA, LLCCPT55002021-08-11
20811870035702Custom Healthcare Systems of VA, LLCA2081V-62021-08-09
20811870035740Custom Healthcare Systems of VA, LLCB9-16350D2021-08-09
20811870035689Custom Healthcare Systems of VA, LLCOSC-200612021-07-30
20811870035665Custom Healthcare Systems of VA, LLCDT-193432021-07-15
20811870035672Custom Healthcare Systems of VA, LLCB9-9754A2021-07-15
20811870035634Custom Healthcare Systems of VA, LLCDT-19714 v22021-07-12
20811870035580Custom Healthcare Systems of VA, LLCL4000-200272021-07-06
20811870035566Custom Healthcare Systems of VA, LLCKM-19796-12021-06-29
20811870035535Custom Healthcare Systems of VA, LLCB9-200082021-06-18
20811870035559Custom Healthcare Systems of VA, LLCCLT-199142021-06-18
20811870035498Custom Healthcare Systems of VA, LLC36774662021-06-11
20811870035474Custom Healthcare Systems of VA, LLCL1000-199362021-06-10
20811870035528Custom Healthcare Systems of VA, LLCL1000-200002021-06-10
20811870035450Custom Healthcare Systems of VA, LLCMWM-18937-022021-06-04
20811870035443Custom Healthcare Systems of VA, LLCZZ-14112021-05-24
20811870035306Custom Healthcare Systems of VA, LLCZZ-14102021-05-07
20811870035382Custom Healthcare Systems of VA, LLCZZ-14132021-05-07
20811870035399Custom Healthcare Systems of VA, LLCZZ-14122021-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956537385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-01
10809160539507HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539514HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539521HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539538HalyardAVID MEDICAL, INC.LRO2026-10-01
10809160539552HalyardAVID MEDICAL, INC.LRO2026-10-01
10198956488564CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956513471CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956519565CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956553989CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956558540CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956559486CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956562684CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956567757CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956567955CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956568273CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956568341CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956570856CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956570870CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956570986CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956581005CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956581159CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956584921CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956585188CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956592520CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956593381CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956593589CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956594241CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956595705CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30
10198956598249CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-30