FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
20811870032183
Brand
Custom Healthcare Systems Inc.
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
D40-11262
Published
2018-07-27
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
20811870032183PackageGS150In Commercial Distribution
00811870032189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003218320811870032183
00811870032189008118700321898118700321890811870032189

GMDN Terms#

Term, Definition table
TermDefinition
Palate prosthesisAn artificial substitute for the hard palate used to reproduce the function of the palate typically in cases of a palatal cleft or fistula, or for palatal augmentation. It will help to improve the patient's speech and eating ability by occluding the defective opening, and in some cases by improving the positioning of their tongue and improving swallowing. Teeth are usually mounted on the device. This is a reusable device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
175254820
Device count
1
DM exempt
false
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
10809160528112HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528136HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528174HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528181HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528198HalyardAVID MEDICAL, INC.LRO2026-07-30
10809160528051HalyardAVID MEDICAL, INC.LRO2026-07-29
10809160528099HalyardAVID MEDICAL, INC.LRO2026-07-29
10653160393511CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-28
10809160527955HALYARDAVID MEDICAL, INC.LRO2026-07-28
10809160527962HALYARDAVID MEDICAL, INC.LRO2026-07-28
10809160527993HalyardAVID MEDICAL, INC.LRO2026-07-28
10809160528044HalyardAVID MEDICAL, INC.LRO2026-07-28
10197106838556CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956355385CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956359512CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956371965CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956384927CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956390102CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956392885CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956393196CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956394735CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956400900CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956401129CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956406544CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956410268CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956423817CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956443136CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956445758CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956445932CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27
10198956457829CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-27