FDA.reportPublic FDA data

Custom Healthcare Systems, Inc.

Primary DI
20811870035931
Brand
Custom Healthcare Systems, Inc.
Company
CUSTOM HEALTHCARE SYSTEMS, INC.
Model
B9-19835
Published
2020-10-13
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
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20811870035931PackageGS110In Commercial Distribution
00811870035937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081187003593120811870035931
00811870035937008118700359378118700359370811870035937

GMDN Terms#

Term, Definition table
TermDefinition
Surgical preparation kitA collection of sterile devices designed for the preoperative preparation of the operative site on a patient's body. It typically includes scrubbing pads (e.g., surgical sponges) and sterilizing/disinfecting solutions. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
175254820
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
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
10198956516014CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
10198956536043CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
10198956538313CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-31
04046826380830Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826380939Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413187Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413194Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413200Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826438180Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826495800Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826495954Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
00198506092343ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-29
03661219268444LANDANGERLANDANGERLRP2026-07-29
00198506093739ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-28
00642356005812SteriBestMastel Surgical Inc.LRP2026-07-28
08057639712660Box AdapterMC BIO SRLLRP2026-07-28
10198956414419CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956488236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956489189CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956492745CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956493025CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956505117CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956509214CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513488CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513716CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513778CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513815CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956520035CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956523609CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956523715CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27