FDA.reportPublic FDA data

Custom Healthcare Systems Inc.

Primary DI
20811870031858
Brand
Custom Healthcare Systems Inc.
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
B9-15620B
Published
2018-07-30
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
OGJNerve Block Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGJNerve Block TrayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870031858PackageGS120In Commercial Distribution
00811870031854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003185820811870031858
00811870031854008118700318548118700318540811870031854

GMDN Terms#

Term, Definition table
TermDefinition
Myelography kitA collection of sterile devices designed for injecting contrast medium into the subarachnoid (intrathecal) space (usually of the lumbar spine) for the purposes of visualizing the spinal canal by radiographic study. 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
10195327297756Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-13
10193489212969Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489215441Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489215885Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489217667Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489415827Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489422481Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489426816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489428780Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489432077Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489432817Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489445497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489447156Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489454994Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
10193489810479Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2023-06-08
H65857032375Henry ScheinHENRY SCHEIN, INC.OGJ2022-12-13
10195327243142Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-11-24
H65857032195Henry ScheinHENRY SCHEIN, INC.OGJ2022-10-25
10193489848304Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-09-04
10193489415780Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-08-04
10193489417999Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-08-04
10193489432091Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-07-03
10193489403879Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-24
10193489216110Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-17
10193489452754Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-17
10193489457605Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-10
10195327022815Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OGJ2022-04-01
10195594513337CARDINAL HEALTHCardinal Health 200, LLCOGJ2022-03-08
10195594502546CARDINAL HEALTHCardinal Health 200, LLCOGJ2022-02-26
10195594504342CARDINAL HEALTHCardinal Health 200, LLCOGJ2022-02-18