FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
20811870030141
Brand
Custom Healthcare Systems Inc.
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
C10-8570
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
OKVObstetrical Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870030141PackageGS150In Commercial Distribution
00811870030147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003014120811870030141
00811870030147008118700301478118700301470811870030147

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
10809160540893HalyardAVID MEDICAL, INC.OKV2026-10-20
10198956586307CARDINAL HEALTHCardinal Health 200, LLCOKV2026-10-19
10809160540671HalyardAVID MEDICAL, INC.OKV2026-10-16
10809160540459HalyardAVID MEDICAL, INC.OKV2026-10-09
10809160540268HalyardAVID MEDICAL, INC.OKV2026-10-08
10809160540305HalyardAVID MEDICAL, INC.OKV2026-10-08
10809160540367HalyardAVID MEDICAL, INC.OKV2026-10-08
10809160540039HalyardAVID MEDICAL, INC.OKV2026-10-07
10809160539903HalyardAVID MEDICAL, INC.OKV2026-10-06
10809160539927HalyardAVID MEDICAL, INC.OKV2026-10-06
10809160539972HalyardAVID MEDICAL, INC.OKV2026-10-06
10809160539811HALYARDAVID MEDICAL, INC.OKV2026-10-05
10809160539859HalyardAVID MEDICAL, INC.OKV2026-10-05
10198956284524CARDINAL HEALTHCardinal Health 200, LLCOKV2026-09-30
10809160538944HalyardAVID MEDICAL, INC.OKV2026-09-24
10809160538982HalyardAVID MEDICAL, INC.OKV2026-09-24
10809160538586HalyardAVID MEDICAL, INC.OKV2026-09-22
10809160538623HalyardAVID MEDICAL, INC.OKV2026-09-22
10809160538180HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538302HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538463HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538500HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160537619HalyardAVID MEDICAL, INC.OKV2026-09-19
10809160537800HALYARDAVID MEDICAL, INC.OKV2026-09-19
10809160536568HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160536650HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537008HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537022HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537053HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160532690HalyardAVID MEDICAL, INC.OKV2026-09-04