FDA.reportPublic FDA data

CUSTOM HEALTHCARE SYSTEMS INC

Primary DI
20811870031001
Brand
CUSTOM HEALTHCARE SYSTEMS INC
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
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
OTC
false
Sterile
false
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/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
175254820
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
false

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
10198956445000CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-05
10809160522776HalyardAVID MEDICAL, INC.OKV2026-06-05
10809160522424HalyardAVID MEDICAL, INC.OKV2026-06-02
10809160522431HalyardAVID MEDICAL, INC.OKV2026-06-02
10198956488229CARDINAL HEALTHCardinal Health 200, LLCOKV2026-06-01
10809160522165HalyardAVID MEDICAL, INC.OKV2026-06-01
10809160522257HalyardAVID MEDICAL, INC.OKV2026-06-01
10809160522141HalyardAVID MEDICAL, INC.OKV2026-05-29
10809160521915HalyardAVID MEDICAL, INC.OKV2026-05-27
10193489991543Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-10-15
10193489214284Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489215823Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489410211Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489412475Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413014Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413809Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489413984Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489419931Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489421637Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489424218Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489425758Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489426694Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489427516Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489428605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489430660Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489431643Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489445053Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489447002Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489454505Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08
10193489454512Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OKV2023-06-08