FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
00811870030147
Brand
Custom Healthcare Systems Inc.
Company
Manus Medical, LLC
Model
C10-8570
Published
2018-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
800604196
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811870037979Manus Medical, LLCZZ-0683-12024-02-06
00811870033216Custom Healthcare Systems Inc.UNC-179142018-07-25
00811870035555Custom Healthcare Systems of VA, LLCCLT-199142021-06-18
00811870030703Custom Healthcare Systems Inc.VBS-18520C2018-10-19
00811870032943CUSTOM HEALTHCARE SYSTEMS, INCDT-0520192019-06-03
00811870034411Custom Healthcare Systems Inc.VBS-18520B2018-10-19
00811870035036Custom Healthcare Systems, Inc.DT-197142020-04-09
00811870035166Custom Healthcare Systems, Inc.CUS1365-022020-07-28
00811870035630Custom Healthcare Systems of VA, LLCDT-19714 v22021-07-12
00811870035661Custom Healthcare Systems of VA, LLCDT-193432021-07-15
00811870035883Custom Healthcare Systems Inc.VBS-191082019-03-07
00811870035890Custom Healthcare Systems Inc.11168030152019-03-07
00811870037863Manus Medical, LLCEMLP-20375-12023-12-20
00811870037986Manus Medical, LLCUNC-9800-02024-02-07
20811870037980Manus Medical, LLCUNC-9800-02024-02-07
20811870037973Manus Medical, LLCZZ-0683-12024-02-06
00811870037887Manus Medical, LLCLPGM-0012024-02-02
00811870037900Manus Medical, LLCLPGM-002-12024-02-02
00811870037917Manus Medical, LLCMMCUS11732024-02-02
00811870037924Manus Medical, LLCA2081V-72024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160532690HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532805HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532843HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532850HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532881HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160531853HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531938HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531969HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532027HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532065HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532096HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531747HalyardAVID MEDICAL, INC.OKV2026-08-26
10809160531761HalyardAVID MEDICAL, INC.OKV2026-08-26
10809160531327HalyardAVID MEDICAL, INC.OKV2026-08-21
10809160531402HalyardAVID MEDICAL, INC.OKV2026-08-21
10809160530290HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160530474HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160530481HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160530498HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160530528HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160530542HalyardAVID MEDICAL, INC.OKV2026-08-18
10809160529362HalyardAVID MEDICAL, INC.OKV2026-08-07
10809160529379HalyardAVID MEDICAL, INC.OKV2026-08-07
10809160528402HalyardAVID MEDICAL, INC.OKV2026-08-03
10809160528471HalyardAVID MEDICAL, INC.OKV2026-08-03
10198956531307CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10198956534094CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10198956536999CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-31
10809160528075HalyardAVID MEDICAL, INC.OKV2026-07-29
10809160527856HalyardAVID MEDICAL, INC.OKV2026-07-28