FDA.reportPublic FDA data

CUSTOM HEALTHCARE SYSTEMS INC

Primary DI
00811870031007
Brand
CUSTOM HEALTHCARE SYSTEMS INC
Company
Manus Medical, LLC
Model
R1676
Published
2018-07-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
20811870031001PackageGS110In Commercial Distribution
00811870031007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003100120811870031001
00811870031007008118700310078118700310070811870031007

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
800604196
Device count
1
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
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
10198956486584CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-16
10809160527269HalyardAVID MEDICAL, INC.OKV2026-07-16
10198956388208CARDINAL HEALTHCardinal Health 200, LLCOKV2026-07-09
10809160526927HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526941HalyardAVID MEDICAL, INC.OKV2026-07-09
10809160526842HalyardAVID MEDICAL, INC.OKV2026-07-08
10809160526811HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526828HalyardAVID MEDICAL, INC.OKV2026-07-07
10809160526507HalyardAVID MEDICAL, INC.OKV2026-07-06
10809160526309HalyardAVID MEDICAL, INC.OKV2026-06-26
10809160525951HalyardAVID MEDICAL, INC.OKV2026-06-24
10198956485075CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-23
10809160525203HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525258HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525265HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525326HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525500HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525593HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160525654HalyardAVID MEDICAL, INC.OKV2026-06-22
10809160523087HalyardAVID MEDICAL, INC.OKV2026-06-09
10809160523117HalyardAVID MEDICAL, INC.OKV2026-06-09
10198956454101CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-08
10809160522837HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522851HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522868HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522882HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522974HalyardAVID MEDICAL, INC.OKV2026-06-08
10809160522998HalyardAVID MEDICAL, INC.OKV2026-06-08
10198956445000CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-05
10809160522776HalyardAVID MEDICAL, INC.OKV2026-06-05