Custom Healthcare Systems of VA, LLC

GUDID 20811870033814

CUSTOM HEALTHCARE SYSTEMS, INC.

General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General/plastic surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use General surgical procedure kit, non-medicated, single-use
Primary Device ID20811870033814
NIH Device Record Key9085f485-ae29-4580-a24a-38c458a80000
Commercial Distribution StatusIn Commercial Distribution
Brand NameCustom Healthcare Systems of VA, LLC
Version Model NumberBGI-19709
Company DUNS175254820
Company NameCUSTOM HEALTHCARE SYSTEMS, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811870033810 [Primary]
GS120811870033814 [Package]
Contains: 00811870033810
Package: NA [25 Units]
In Commercial Distribution

FDA Product Code

LROGeneral Surgery Tray

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

[20811870033814]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-05
Device Publish Date2021-04-27

On-Brand Devices [Custom Healthcare Systems of VA, LLC]

00811870035371KM-CBMT
20811870033814BGI-19709
20811870035436ZZ-1408
20811870035429ZZ-1409
20811870035399ZZ-1412
20811870035382ZZ-1413
20811870035306ZZ-1410
20811870035443ZZ-1411
20811870035450MWM-18937-02
20811870035528L1000-20000
20811870035474L1000-19936
208118700354983677466
20811870035559CLT-19914
20811870035535B9-20008
20811870035566KM-19796-1
20811870035580L4000-20027
20811870035634DT-19714 v2
20811870035672B9-9754A
20811870035665DT-19343
20811870035689OSC-20061
20811870035740B9-16350D
20811870035702A2081V-6
20811870035962CPT5500
20811870035757CPT5610
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.