FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
20811870032374
Brand
Custom Healthcare Systems Inc.
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
3404253NBN
Published
2019-03-20
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
DWONeedle, Biopsy, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWONeedle, Biopsy, CardiovascularGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870032374PackageGS110In Commercial Distribution
00811870032370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003237420811870032374
00811870032370008118700323708118700323700811870032370

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow biopsy procedure kitA packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use 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
10884450681203Preston™Merit Medical Systems, Inc.DWO2026-02-03
04046964993312AESCULAPAESCULAP, INC.DWO2026-01-16
04046964993329AESCULAPAESCULAP, INC.DWO2026-01-16
08057276004814Cell-HarvestORM.D.L. S.R.L.DWO2025-04-29
08057276004821Bone-HarvestORM.D.L. S.R.L.DWO2025-04-29
G6352120052MAMAWIREHISTO S.A.DWO2024-05-17
G6352120072MAMAWIREHISTO S.A.DWO2024-05-17
G6352120102MAMAWIREHISTO S.A.DWO2024-05-17
G6352120122MAMAWIREHISTO S.A.DWO2024-05-17
G6352120132MAMAWIREHISTO S.A.DWO2024-05-17
G6352120152MAMAWIREHISTO S.A.DWO2024-05-17
G6353120052MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120072MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120102MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120122MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120132MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G6353120152MAMAWIRE PLUSHISTO S.A.DWO2024-05-17
G635360015DANA 2.2 MG GHISTO S.A.DWO2024-05-17
G635360015G1DANA 2.2 MG GHISTO S.A.DWO2024-05-17
G6358120202BLO-KHISTO S.A.DWO2024-05-17
G6358120252BLO-KHISTO S.A.DWO2024-05-17
G6359118102MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810B2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810D2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DB2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G635911810DY2MAMAWIRE FIXHISTO S.A.DWO2024-05-17
G6355512102BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551210C2BIOCORE II MGHISTO S.A.DWO2024-05-16
G6355512132BIOCORE II MGHISTO S.A.DWO2024-05-16
G635551213C2BIOCORE II MGHISTO S.A.DWO2024-05-16